New FDA Drug Approvals - July 2021


drospirenone and estetrol

Nextstellis

Pharmaceutical company: Mayne Pharma

Pharmacologic classification:Estrogen-progestin combination

Therapeutic classification:Endocrine-metabolic agents

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tivozanib

Fotivda

Pharmaceutical company: AVEO Pharmaceuticals

Pharmacologic classification:Kinase inhibitor

Therapeutic classification:Antineoplastic

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viloxazine

Qelbree

Pharmaceutical company: Supernus Pharmaceuticals

Pharmacologic classification:Selective norepinephrine reuptake inhibitor

Therapeutic classification:ADHD drug

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New FDA Drug Approvals Archive


New FDA Drug Approvals - July 2021
drospirenone and estetrolNextstellisPharmaceutical company: Mayne PharmaPharmacologic classification:Estrogen-progestin combinationTherapeutic classification:Endocrine-metabolic agentsREAD MORE...AVAILABLE FORMSTablets: 3 mg drospirenone and 14.2 mg estetrol as 24 active tablets, and 4 inert tablets per packINDICATIONS AND DOSAGESTo prevent pregnancy in females of reproductive potentialWomen with no current use of hormonal contraception: One active tablet PO daily for 24 days beginning on day 1 of menstrual cycle. Then one inert tablet PO daily for 4 days. Begin each subsequent 28-day pack on the same day of the week as the first cycle pack; restart active tablets the next day after last inert tablet.Women switching from another contraceptive method: One active tablet PO daily for 24 days beginning on the day when previous combined oral contraceptive would have started; or on the day when a new transdermal system, vaginal insert, or injection would have been scheduled; or on the day after removal of intrauterine system or implant; or on the day after the last progestin-only pill was taken. Then one inert tablet PO daily for 4 days. Begin each subsequent 28-day pack on the same day of the week as the first cycle pack; restart active tablets the next day after the last inert tablet.Women starting after delivery of more than 20 weeks’ gestation or abortion or miscarriage after more than 14 weeks’ to 20 weeks’ or less gestation: Beginning no earlier than 4 weeks after delivery, follow directions for women with no current use of hormonal contraception if menses have resumed. If menses have not resume and the woman is not pregnant, use additional nonhormonal contraception for the first 7 days of use.Women starting after abortion or miscarriage after 14 weeks’ or less gestation: Followdirections for women with no current use of hormonal contraception. If within the first 7 days after abortion or miscarriage, use additional nonhormonal contraception for the next 7 days.CONTRAINDICATIONS AND CAUTIONSContraindicated in females with a high risk of arterial or venous thrombotic diseases; evaluate patient for any past personal or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy before starting medication. Risk factors for venous thromboembolism (VTE) (deep vein thrombosis, pulmonary embolism) include smoking, obesity, family history of VTE and prolonged immobilization.Contraindicated in females with current or history of a hormonally-sensitive malignancy (breast cancer), hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or decompensated cirrhosis.Contraindicated in women with uterine bleeding of undiagnosed etiology.Contraindicated in females predisposed to hyperkalemia (renal impairment, hepatic impairment, adrenal insufficiency).Contraindicated in patients with uncontrolled hypertension (HTN) or HTN with vascular disease.Contraindicated in females who have migraines with aura; discontinue medication in females who develop new migraines that are recurrent, persistent, or severe, or who have an increase in frequency or severity of migraines with medication use.Avoid use in females with hereditary angioedema; medication may induce or exacerbate symptoms.Avoid use in females with a history of chloasma gravidarum or increased sensitivity to sun or ultraviolet exposure.This drug may be less effective in females with a BMI of 30 kg/m2 or greater. Safety and efficacy in females with a BMI 35 kg/m2 or greater have not been established.Use of combined hormonal contraceptives may increase risk of CV events and is greatest in females over age 40, those with HTN, dyslipidemia, diabetes, or obesity, and those who use nicotine-containing products.Use cautiously in females with prediabetes or diabetes; medication may decrease glucose tolerance.Consider an alternate contraceptive method in females with personal or family history of hypertriglyceridemia; medication may increase triglyceride level and the risk for pancreatitis.Medication may increase the risk of developing or worsening existing gallbladder disease. Consider discontinuing use in females with symptomatic gallbladder or cholestatic disease.Dialyzable drug: Unknown.Overdose S&S: Nausea, vomiting, severe headache, thromboembolic complications, vaginal bleeding.PREGNANCY-LACTATION-REPRODUCTIONDiscontinue hormonal contraceptives if pregnancy occurs.Hormonal contraceptives are present in human breast milk and may decrease milk production. Advise women who are breastfeeding to switch to an alternative form of birth control, if possible, taking into consideration the benefits of breastfeeding and the mother’s clinical need for contraception.INTERACTIONSDrug-drug. Antibiotics: May reduce contraceptive effectiveness. Advise use of backup contraception during coadministration.Antidiabetic drugs: May reduce the blood glucose lowering effect of antidiabetic drugs. Increase frequency of glucose monitoring and increase antidiabetic drug dosage, as needed, based on glucose levels.Bile acid sequestrants (cholestyramine, colesevelam, colestipol): May decrease absorption of contraceptive and lead to contraceptive failure or increase in breakthrough bleeding. Separate time of administration and refer to the sequestrants prescribing information for additional information.Drugs that may increase serum potassium level (ACE inhibitors, ARBs, NSAIDs spironolactone, potassium supplements):Mayincrease serum potassium level. Monitor serum potassium level.Hepatitis C drug combinations containing ombitasvir–paritaprevir–ritonavir, with or without dasabuvir: May increase liver enzymes. Use together is contraindicated. May start drospirenone and estetrol 2 weeks after completion of hepatitis C combination drug regimen.Lamotrigine:May decrease lamotrigine efficacy. Adjust lamotrigine dosage as recommended in prescribing information.Moderate and weak CYP3A4 inducers (dabrafenib, dexamethasone, modafinil, nafcillin): May lead to contraceptive failure. Use an alternative or backup contraceptive method during coadministration and up to 28 days after discontinuation of the CYP3A inducer, unless the prescribing information of the inducer indicates no clinically significant interaction.Strong CYP3A inducers (phenytoin, phenobarbital, dexamethasone, rifamycin, rifampin): May lead to contraceptive failure. Avoid concomitant use. If concomitant use is unavoidable, use an alternative contraceptive method or backup nonhormonal contraceptive method during coadministration and up to 28 days after discontinuation of the inducer.Strong CYP3A inhibitors (ketoconazole, saquinavir, loperamide, diltiazem): May increase risk of adverse drug reactions. Monitor serum potassium level in patients taking concomitantly long term.Systemic corticosteroids:May increase the risk of corticosteroid-related adverse reactions. Monitor patient closely. Follow the recommendation for the corticosteroid in accordance with its prescribing information.Thyroid hormone replacement therapy: May increase thyroid-binding globulin level. Monitor thyroid-stimulating hormone level and follow the recommendation for thyroid hormone replacement in accordance with its prescribing information.Drug-herb. St. John’s wort:May reduce contraceptive effectiveness or increase breakthrough bleeding. Discourage use together or recommend alternative method of birth control.Drug-lifestyle. Black Box Warning: Smoking: Cigarette smoking increases the risk of serious CV events from combined hormonal contraceptive use. Use together is contraindicated in females over age 35.Sun and ultraviolet light:Drug may increase risk of chloasma. Limit exposure and wear sunscreen while taking this medication.ADVERSE REACTIONSCNS: headache, mood disturbance.CV: thromboembolic disorders.GU: libido decrease, bleeding irregularities.Metabolic: dysmenorrhea, weight increase.Skin: acne.Other: breast symptoms.Reactions in bold italics are life-threatening.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwertivozanibFotivdaPharmaceutical company: AVEO PharmaceuticalsPharmacologic classification:Kinase inhibitorTherapeutic classification:AntineoplasticREAD MORE...AVAILABLE FORMSCapsules: 0.89 mg, 1.34 mgINDICATIONS AND DOSAGESTreatment of relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapiesAdults: 1.34 mg PO once daily for 21 days followed by 7 days off treatment for a 28-day cycle. Continue treatment until disease progression or unacceptable toxicity.Adjust-a-dose: If moderate hepatic impairment (total bilirubin greater than 1.5 to 3 times the upper limit of normal [ULN] with any AST), decrease dosage to 0.89 mg. Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSThis drug may cause severe hypertension and hypertensive crisis. Control blood pressure prior to initiating therapy and monitor the patient closely.This drug may cause serious or fatal cardiac failure, cardiac ischemia, arterial or venous thromboembolic events (MI, stroke), or hemorrhagic events. Closely monitor patients at risk for these events or those with a history of these events. Discontinue the drug if severe or life-threatening events occur.This drug may increase the risk of impaired wound healing; withhold therapy for at least 24 days before elective surgery and for at least 2 weeks following major surgery until adequate wound healing has occurred.This drug may cause reversible posterior leukoencephalopathy syndrome (RPLS). Evaluate patients with seizures, headaches, visual disturbances, confusion, or altered mental function with magnetic resonance imaging. Discontinue the drug in patients who develop RPLS.The 0.89-mg capsule contains FD&C Yellow No.5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in susceptible patients.Safety and effectiveness have not been established in pediatric patients, or in patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times ULN with any AST).Dialyzable drug: Unknown.Overdose S&S: Hypertension and hypertensive crisis.PREGNANCY-LACTATION-REPRODUCTIONBased on animal studies and mechanism of action, this drug can cause fetal harm. Advise women who are pregnant of the risk.Verify pregnancy status of females of reproductive potential prior to start of treatment.Females of reproductive potential and male patients with female partners of reproductive potential should use effective contraception during treatment and for one month after the last dose.There are no data on the presence of this drug in human milk, or the effects of this drug on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise a woman who is lactating not to breastfeed during treatment or for one month after the last dose.This drug can impair fertility in males and females of reproductive potential.INTERACTIONSDrug-drug. Strong CYP3A inducers (rifampin, carbamazepine, phenytoin): May decrease tivozanib levels. Avoid use together.ADVERSE REACTIONSCNS: fatigue, delirium.CV: bleeding, cardiac failure, cardiac ischemia, venous thromboembolism, arterial thromboembolism, hypertension.EENT: dysphonia.GI: diarrhea, nausea, stomatitis, vomiting, decreased appetite.GU: acute kidney injury, proteinuria, increased creatinine.Hematologic: decreased lymphocytes, decreased platelets, prolonged activated partial thromboplastin time, increased or decreased hemoglobin.Hepatic: hepatobiliary disorders.Metabolic: hypothyroidism, decreased weight.Musculoskeletal: back pain, osteonecrosis.Respiratory: pneumonia, respiratory failure, cough, dyspnea.Skin: rash, palmar-plantar erythrodysesthesia syndrome.Other: hypothyroidism.Reactions in bold italics are life-threatening.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerviloxazineQelbreePharmaceutical company: Supernus PharmaceuticalsPharmacologic classification:Selective norepinephrine reuptake inhibitorTherapeutic classification:ADHD drugREAD MORE...AVAILABLE FORMSCapsules (extended-release): 100 mg, 150 mg, 200 mgINDICATIONS AND DOSAGESTreatment of attention-deficit hyperactivity disorder (ADHD)Children ages 6 to 11 years: Initially, 100 mg PO once daily. May titrate by increments of 100 mg weekly to the maximum dose of 400 mg daily, depending on response and tolerability.Children ages 12 to 17 years: Initially,200 mg PO once daily. After one week, may titrate by increments of 200 mg to the maximum dose of 400 mg daily, depending on response and tolerability.Adjust-a-dose: For severe renal impairment (eGFR less than 30 mL/min/1.73 m2), the recommended starting dose is 100 mg once daily. May titrate weekly by increments of 50 to 100 mg once daily, to a maximum dose of 200 mg once daily.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: Suicidal thoughts and behavior may increase when treated with this drug; monitor patients closely.This drug may induce manic or mixed episodes in patients with bipolar disorder. Screen patients prior to therapy for risk of bipolar disorder, including a detailed psychiatric history with personal and family history of suicide, bipolar disorder, and depression.Use cautiously in those with severe renal impairment.Use is not recommended in those with hepatic impairment.Safety and effectiveness have not been established in children younger than age 6.Dialyzable drug: Unknown.Overdose S&S: Drowsiness, impaired consciousness, diminished reflexes, and increased heart rate.PREGNANCY-LACTATION-REPRODUCTIONBased on animal studies, this drug may cause maternal and fetal harm when used during pregnancy. Discontinue when pregnancy is recognized, unless benefits to mother outweigh the risk.Health care providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or online at www.womensmentalhealth.org/preg.This drug may be present in breast milk. Consider the benefits of breastfeeding along with the mother’s need for the drug, and the risk to the child.INTERACTIONSDrug-drug. CYP2D6 substrates (atomoxetine, desipramine, dextromethorphan, nortriptyline, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone); CYP3A4 substrates (atiplfentanil, avanafil, buspirone, conivaptan, darifenacin, darunavir, ebastine, everolimus, ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, vardenafil, lurasidone): May increase levels of these substrates and risk for adverse reactions. Monitor patient closely and adjust dose of the substrates as clinically indicated.Drugs that are moderately sensitive CYP1A2 substrates (clozapine, pirfenidone): May increase levels of sensitive substrates and risk for adverse reactions. Use together is not recommended. If coadministered, substrate dose reduction may be warranted.Drugs that are sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, theophylline): May increase levels of sensitive substrates and risk for adverse reactions. Use together is contraindicated.MAO inhibitors: (selegiline, isocarboxazid, phenelzine, tranylcypromine, safinamide, rasagiline):May increase the risk of hypertensive crisis with concomitant treatment or within 14 days after discontinuing MAO inhibitor. Use during this timeframe is contraindicated.ADVERSE REACTIONSCNS: somnolence, fatigue, insomnia, lethargy, sedation, irritability, headache, pyrexia.CV: increased diastolic blood pressure, tachycardia.EENT: upper respiratory infection.GI: decreased appetite,nausea, vomiting, abdominal discomfort or pain.Reactions in bold italics are life-threatening.Released: July 2021Nursing Drug Handbook© 2021 Wolters KluwerDownload these updates as a PDF
New FDA Drug Approvals - June 2021
dasiglucagonZegaloguePharmaceutical company: Zealand PharmaPharmacologic classification:Glucagon receptor agonistTherapeutic classification:AntihypoglycemicREAD MORE...AVAILABLE FORMSInjection: 0.6 mg/0.6 mL single-dose autoinjector; 0.6 mg/0.6 mL single-dose prefilled syringeINDICATIONS AND DOSAGESTreatment of severe hypoglycemia in patients with diabetesAdults and children age 6 and older: 0.6-mg subcut injection. If no response after 15 minutes, may repeat with an additional 0.6 mg subcut.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with pheochromocytoma. If a patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, consider giving 5 to 10 mg of phentolamine mesylate IV.Contraindicated in patients with insulinoma. This drug may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of dasiglucagon, give PO or IV glucose.Allergic reactions have been reported with glucagon products.This drug is effective in treating hypoglycemia only if sufficient hepatic glycogen stores are present. Patients in a starvation state, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for the drug to be effective. Treat these patients with glucose.The safety and effectiveness of this drug have not been established in patients younger than age 6.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on dasiglucagon use in pregnant females. However, untreated hypoglycemia in pregnancy can cause complications and may be fatal.There is no information on the presence of this drug in human milk, its effects on the breastfed infant, or milk production. Dasiglucagon would be expected to be broken down to amino acids in the infant's digestive tract and is therefore unlikely to cause harm to an exposed infant.INTERACTIONSDrug-drug. Beta-blockers: May transiently increase pulse and blood pressure. Monitor patient’s vital signs.Indomethacin: May decrease antihypoglycemic effect of dasiglucagon or may produce hypoglycemia. Use together cautiously.Warfarin: May increase anticoagulant effect of warfarin. Monitor patient closely.ADVERSE REACTIONSCNS: headache.CV: hypertension, hypotension, bradycardia, presyncope, palpitations, orthostatic intolerance.GI: nausea, vomiting, diarrhea.Skin: injection site pain.Other: hypersensitivity reactions.Reactions in bold italics are life-threatening.Released: June 2021© 2021 Wolters Kluwermelphalan flufenamidePepaxtoPharmaceutical company: Oncopeptides Inc.Pharmacologic classification:Nitrogen mustardTherapeutic classification:AntineoplasticREAD MORE...AVAILABLE FORMSInjection: 20-mg single-dose vialINDICATIONS AND DOSAGESRelapsed or refractory multiple myeloma, in combination with dexamethasone, in those who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibodyAdults: 40-mg IV infusion over 30 minutes on day 1 of each 28-day cycle in combination with dexamethasone 40 mg PO or IV on days 1, 8, 15 and 22 of each cycle until disease progression or until unacceptable toxicity.Adjust-a-dose: For patients age 75 or older, reduce dose of dexamethasone to 20 mg. Refer to the manufacturer’s instruction for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients hypersensitive to melphalan flufenamide or melphalan.Dosages exceeding the recommended dose for relapsed and refractory multiple myeloma are associated with mortality.This drug may increase the risk of secondary malignancies, such as myelodysplastic syndromes or acute leukemia. Monitor patients long-term for secondary malignancies.This drug is not indicated or recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.This drug has not been studied in patients with creatinine clearance 15 to 44 mL/min.Safety and effectiveness in children have not been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise pregnant women of the risk to a fetus.Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.Verify pregnancy status in females of reproductive potential prior to initiating this drug.Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.There is potential for serious adverse reactions in a breastfed child; advise women not to breastfeed during treatment and for 1 week after the last dose.This drug can cause amenorrhea and result in infertility.This drug may impair male fertility and irreversible testicular suppression.INTERACTIONSNone reported.ADVERSE REACTIONSCNS: pyrexia, fatigue, asthenia, headache, dizziness, insomnia.CV: peripheral edema, hemorrhage.GI: nausea, diarrhea, constipation, vomiting, decreased appetite.Hematologic: thrombocytopenia, neutropenia, febrile neutropenia, leukopenia, hemorrhages, anemia.Metabolic: hypokalemia, hypocalcemia.Musculoskeletal: bone pain, back pain, arthralgia, extremity pain.Respiratory: pneumonia, respiratory tract infection, respiratory failure, cough, dyspnea, exertional dyspnea.Other: sepsis, general physical health deterioration, hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: June 2021© 2021 Wolters Kluwer ponesimodPonvoryPharmaceutical company: Janssen PharmaceuticalsPharmacologic classification:Sphingosine 1-phosphate receptor modulatorTherapeutic classification:Multiple sclerosis drugREAD MORE...AVAILABLE FORMSTablets: 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, and 20 mgINDICATIONS AND DOSAGESRelapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive diseaseAdults: Initially, one tablet PO daily from starter pack for days 1 to 14: days 1 and 2, 2 mg; days 3 and 4, 3 mg; days 5 and 6, 4 mg; day 7, 5 mg; day 8, 6 mg; day 9, 7 mg; day 10, 8 mg; day 11, 9 mg; days 12 to 14, 10 mg;then begin maintenance dose of 20 mg PO once daily starting on day 15.CONTRAINDICATIONS AND CAUTIONSContraindicated in those with a history of MI, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III or IV heart failure within the last 6 months.Contraindicated in those with Mobitz type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker.Use in those with moderate or severe hepatic impairment (Child-Pugh class B and C) is not recommended.Use cautiously in patients with preexisting heart and cerebrovascular conditions, hypertension, arrhythmias, prolonged QTc interval, risk for prolonged QTc interval; or concurrent drug therapy that slows the heart rate or AV conduction, or prolongs the QTc interval after consultation with a cardiologist on a monitoring strategy.Use cautiously in those with severe respiratory disease (pulmonary fibrosis, asthma, chronic obstructive pulmonary disease). Dose-dependent reductions in respiratory function were seen in patients treated with this drug.Use cautiously in patients with a history of uveitis or diabetes; this drug may increase the risk of macular edema. Regular follow-up examinations of the fundus should be obtained in these patients. This drug may increase the risk of infections, including life-threatening and rare fatal infections.This drug may cause severe exacerbation of MS, including disease rebound, after discontinuation. Monitor patient closely and treat as clinically indicated.Safety and effectiveness in children have not been established.Use cautiously in elderly patients because of the potential for decreased hepatic, renal, or cardiac function, concomitant disease, or other drug therapy.Dialyzable drug: No.Overdose S&S: bradycardia, AV conduction block.PREGNANCY-LACTATION-REPRODUCTIONThis drug may cause fetal harm. Advise women of childbearing potential of the risk prior to the start of treatment.Women of childbearing potential should use effective contraception during and for 1 week after the end of therapy.There are no data on the safety of breastfeeding, effects on the breastfed infant or the production of human milk. Consider benefits of breastfeeding, clinical need of the drug to the mother, and potential adverse effects on the infant.INTERACTIONSDrug-drug. Alemtuzumab: Alemtuzumab effects are prolonged and may have additive immune suppressive effects. Initiating treatment with ponesimod after alemtuzumab is not recommended.Antineoplastic, immunosuppressive, or immune-modulating therapies: Use together cautiously due to additive immunosuppressive effects. When switching from drugs with prolonged immune effects, consider half-life and mode of action of these drugs.Beta-blockers (atenolol, metoprolol, carvedilol, labetalol): May have additive heart rate lowering effects. Use cautiously together; dose interruption of beta-blocker may be necessary. Beta-blocker can be initiated in those receiving stable doses of ponesimod.Beta interferon or glatiramer acetate: May have additive immunosuppressive effects, but ponesimod can generally be started immediately after discontinuation of these drugs.Alert: Drugs that prolong QT interval (class Ia [quinidine, procainamide] and class III [amiodarone, sotalol] antiarrhythmics, verapamil, diltiazem, or other drugs that may decrease heart rate [digoxin]):May have additive effects on heart rate. Consult cardiologist prior to use together.Drugs that slow heart rate or AV conduction:May have additive effects.Monitor patient closely and consult a cardiologist as appropriate.Live-attenuated vaccine immunizations: May increase risk of infection. Administer live-attenuated vaccine at least 1 month prior to initiation of ponesimod and avoid during and from 1 to 2 weeks after treatment with ponesimod.Strong CYP3A4 and UGT1A1 inducers (rifampin, phenytoin, carbamazepine): May decrease ponesimod levels. Use together is not recommended.Vaccines: Drug may decrease effectiveness of vaccine during treatment and for up to 1 to 2 weeks after discontinuations. Avoid giving vaccines until 2 weeks after end of treatment.Drug-lifestyle. Sun exposure: May cause an increase in cutaneous malignancies. Limit exposure to sunlight and ultraviolet light.ADVERSE REACTIONSCNS: dizziness, somnolence, pyrexia, vertigo, fatigue, migraine, insomnia, depression, seizures.CV: bradycardia,AV conduction delay, hypertension, chest discomfort, peripheral edema.EENT: rhinitis, dry mouth, sinusitis, macular edema.GI: dyspepsia.GU: UTI.Hepatic: increased liver function tests.Metabolic: hypercholesterolemia.Musculoskeletal: joint swelling, back pain.Respiratory: upper respiratory infection,dyspnea, cough, pneumonia.Other: extremity pain, increased C-reactive protein, infections.Reactions in bold italics are life-threatening.Released: June 2021© 2021 Wolters Kluwer Download these updates as a PDF
New FDA Drug Approvals - May 2021
Download these updates as a PDFserdexmethylphenidate–dexmethylphenidateAzstarysPharmaceutical company: Corium, Inc.Pharmacologic classification:Norepinephrine and dopamine reuptake inhibitorsTherapeutic classification:CNS stimulantsControlled substance schedule: CII AVAILABLE FORMSCapsules: serdexmethylphenidate–dexmethylphenidate: 26.1 mg/5.2 mg; 39.2 mg/7.8 mg; 52.3 mg/10.4 mgINDICATIONS AND DOSAGESAttention deficit hyperactivity disorder (ADHD)Adults and children age 13 and older: Initially, serdexmethylphenidate–dexmethylphenidate 39.2 mg/7.8 mg PO once daily in the morning. Increase after 1 week to the maximum recommended dosage of serdexmethylphenidate–dexmethylphenidate 52.3 mg/10.4 mg PO daily.Children ages 6 to 12 years: Initially, serdexmethylphenidate–dexmethylphenidate 39.2 mg/7.8 mg PO once daily in the morning. Dose may be increased after 1 week to serdexmethylphenidate–dexmethylphenidate 52.3 mg/10.4 mg PO once daily or decreased to serdexmethylphenidate–dexmethylphenidate 26.1 mg/5.2 mg PO daily depending on response and tolerability. Maximum dosage is serdexmethylphenidate–dexmethylphenidate 52.3 mg/10.4 mg PO daily.Adjust-a-dose: Reduce the dose or discontinue the drug if paradoxical aggravation of ADHD symptoms or other adverse reactions occur. Periodically discontinue the drug to assess a pediatric patient’s condition. If improvement is not observed after appropriate dosage adjustment over 1 month, discontinue the drug.CONTRAINDICATIONS AND CAUTIONSBlack Box Warning: This product and other CNS stimulants (methylphenidate-containing products, amphetamines) have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.Contraindicated in patients with hypersensitivity to serdexmethylphenidate, methylphenidate, or other components of this product. Bronchospasm, rash, and pruritus have been reported. Hypersensitivity reactions (angioedema, anaphylactic reactions) have been reported in patients treated with other methylphenidate products.Avoid use in patients with structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. Assess for cardiac disease (cardiac history, family history of sudden death or ventricular arrhythmia, and physical exam). Sudden death, stroke, and MI have been reported with CNS stimulants at recommended doses. Evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment.CNS stimulants cause an increase in blood pressure and heart rate. Monitor for hypertension and tachycardia.CNS stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon. Signs and symptoms generally improve after dose reduction or drug discontinuation.CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder.CNS stimulants may induce a manic or mixed mood episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).In patients without a prior history of psychotic illness or mania, CNS stimulants at recommended doses, may cause psychotic or manic symptoms (hallucinations, delusional thinking, or mania). If such symptoms occur, consider discontinuing the stimulant.Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products. Priapism developed after some time on the drug, often during a drug holiday, or after a dosage increase or drug discontinuation.CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth in children. Pediatric patients not growing or gaining weight as expected may need to have therapy interrupted or discontinued.Do not substitute this product for other methylphenidate products on a mg-per-mg basis since these have different pharmacokinetic profiles and may have different methylphenidate base composition.The long-term efficacy of methylphenidate in pediatric patients has not been established.The safety and effectiveness of the product in patients younger than age 6 have not been established.Use in patients age 65 and older has not been studied.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThere are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.The use of CNS stimulants during pregnancy can cause vasoconstriction and decrease placental perfusion. No fetal or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low-birth-weight infants have been reported in amphetamine-dependent mothers.Health care providers are encouraged to register female patients in the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.There are no available data on the presence of serdexmethylphenidate in human milk, effects on the breastfed infant, or effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the product and any potential adverse effects on the breastfed infant or from the underlying maternal condition.Monitor breastfeeding infants for adverse reactions (agitation, anorexia, and reduced weight gain).INTERACTIONSDrug-drug. MAO inhibitors (selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue): May cause hypertensive crisis. Do not administer concomitantly with or within 14 days of discontinuing MAO inhibitor.Antihypertensive drugs (potassium-sparing and thiazide diuretics, calcium channel blockers, ACE inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists): May decrease effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.Halogenated anesthetics (halothane, isoflurane, enflurane, desflurane, sevoflurane): May increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid concomitant use on the day of surgery.Risperidone: May increase the risk of extrapyramidal symptoms (EPS) when there is an increase or decrease in dosage of either or both medications. Monitor for signs of EPS.Serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, opioids): May increase risk of serotonin syndrome. Use cautiously together.ADVERSE REACTIONSCNS: insomnia, anxiety, affect lability, irritability, dizziness, fever, seizure, dyskinesia, serotonin syndrome, nervousness, headache, tremor, drowsiness, vertigo, disorientation, hallucination, auditory hallucination, visual hallucination, logorrhea, mania, restlessness, agitation.CV: increased blood pressure, tachycardia, angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate, chest pain, chest discomfort, Raynaud phenomenon.EENT: diplopia, mydriasis, visual impairment, blurred vision, dry mouth.GI: nausea, abdominal pain, dyspepsia, vomiting, decreased appetite.GU: change in libido, priapism.Hematologic: pancytopenia, thrombocytopenia, thrombocytopenic purpura.Hepatic: hepatocellular injury, acute hepatic failure.Metabolic: decreased weight.Musculoskeletal: arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps.Skin: alopecia, erythema, hyperhidrosis.Other: hypersensitivity reactions (angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus necrotizing enterocolitis [NEC], rashes, eruptions, and exanthems NEC).Reactions in bold italics are life-threatening.Released: May 2021© 2021 Wolters Kluwer tepotinibTepmetkoPharmaceutical company: EMD Serono, Inc.Pharmacologic classification:Kinase inhibitorTherapeutic classification:Antineoplastic AVAILABLE FORMSTablets: 225 mgINDICATIONS AND DOSAGESMetastatic non–small-cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterationsAdults: 450 mg PO daily until disease progression or unacceptable toxicity.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments. Permanently discontinue the drug in those who are unable to tolerate 225 mg orally once daily.CONTRAINDICATIONS AND CAUTIONSUse cautiously in those with severe renal or hepatic impairment.This drug may cause interstitial lung disease (ILD)/pneumonitis. Immediately withhold therapy in patients with suspected ILD/pneumonitis. Permanently discontinue therapy in patients with a confirmed diagnosed with ILD/pneumonitis of any severity.This drug may cause hepatotoxicity. Monitor liver function tests. Withhold, reduce dose, or permanently discontinue therapy based on severity.Safety and effectiveness in children have not been established.Use in patients with severe renal impairment (creatinine clearance greater than 30 mL/min) and severe hepatic impairment (Child Pugh C) have not been studied.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise pregnant women of the potential harm to a fetus.Verify pregnancy status in females of reproductive potential prior to initiating.Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the final dose.Advise women not to breastfeed during treatment and for 1 week after the final dose.INTERACTIONSDrug-drug. P-glycoprotein (P-gp) substrates (dabigatran, digoxin, morphine, cyclosporine, sirolimus): May increase the concentration of P-gp substrate levels and increase the incidence and severity of adverse reactions. Avoid concomitant use where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.Strong CYP3A inducers (phenytoin, rifampin): May decrease tepotinib level. Avoid concomitant use.Strong CYP3A inhibitors (ketoconazole, nefazodone, ritonavir) and P-gp inhibitors: May increase tepotinib level and the incidence and severity of adverse reactions. Avoid concomitant use.ADVERSE REACTIONSCNS: fatigue, asthenia, fever, dizziness, headache.CV: edema, pulmonary embolism.GI: nausea, diarrhea, abdominal pain, constipation, vomiting, decreased appetite.Hematologic: lymphocytopenia, decreased albumin, decreased hemoglobin.Hepatic: hepatotoxicity, hepatic pain.Metabolic: decreasedsodium, increased liver function tests.Musculoskeletal: musculoskeletal pain.Respiratory: ILD/pneumonitis, pleural effusion, pneumonia, dyspnea, cough.Skin: rash, pruritus.Other: general health deterioration.Reactions in bold italics are life-threatening.Released: May 2021 © 2021 Wolters Kluwer trilaciclibCoselaPharmaceutical company: G1 TherapeuticsPharmacologic classification:Kinase inhibitorTherapeutic classification:Antineoplastic AVAILABLE FORMSInjection: 300-mg single-dose vialINDICATIONS AND DOSAGESDecrease the incidence of chemotherapy-induced myelosuppression when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small-cell lung cancerAdults: 240 mg/m2-IV infusion over 30 minutes completed within 4 hours prior to start of chemotherapy on each day of chemotherapy. If given on sequential days, the interval between doses of trilaciclib should not be greater than 28 hours.Adjust-a-dose: Refer to the manufacturer’s instructions for toxicity-related dosage adjustments.CONTRAINDICATIONS AND CAUTIONSContraindicated in patients with a history of serious hypersensitivity reactions to this drug. Reactions have included anaphylaxis.Use is not recommended in patients with moderate or severe hepatic impairment (total bilirubin greater than 1.5 times the upper limit of normal, irrespective of AST)Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur.Safety and effectiveness in children have not been established.Dialyzable drug: Unknown.PREGNANCY-LACTATION-REPRODUCTIONThis drug can cause fetal harm. Advise pregnant women of the risk.For females of reproductive potential, a pregnancy test is recommended prior to treatment.There are no data on the presence of this drug in human milk, effects on the breastfed child, or effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise lactating females to not breastfeed while taking this drug and for at least 3 weeks after the last dose.Females of reproductive potential should use an effective method of contraception during treatment with this drug and for at least 3 weeks after the last dose.This drug may impair female fertility.INTERACTIONSDrug-drug. Cisplatin: May increase risk of cisplatin-related nephrotoxicity. Closely monitor renal function.Dalfampridine: May increase dalfampridine blood levels and the risk of seizures. Use together cautiously.Dofetilide: May increase dofetilide blood levels and the risk of serious ventricular arrhythmias associated with QT interval prolongation, including torsades de pointes. Use cautiously together.OCT2, MATE1, and MATE-2K substrates (metformin):May increase substrate level. Avoid concomitant use with certain substrates where minimal concentration changes may lead to serious or life-threatening toxicities.ADVERSE REACTIONSCNS: asthenia, fatigue, headache.CV: thrombosis, hemorrhage, peripheral edema.GI: upper abdominal pain.Hematologic: neutropenia, febrile neutropenia, anemia, thrombocytopenia, leukopenia.Hepatic: increased AST.Metabolic: hypocalcemia, hypokalemia, hypophosphatemia, hyperglycemia.Respiratory: respiratory failure, pneumonia.Skin: injection-site reaction, rash.Other: hypersensitivity reaction.Reactions in bold italics are life-threatening.Released: May 2021© 2021 Wolters Kluwer