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New FDA Drug Approvals - October 2025

darolutamide

Nubeqa

Pharmaceutical company: Bayer HealthCare Pharmaceuticals

Pharmacologic classification: Antineoplastics

Therapeutic classification: Androgen receptor inhibitors


AVAILABLE FORMS

Tablets: 300 mg


INDICATIONS AND DOSAGES Adjust-a-dose (all indications): For patients with eGFR 15 to 29 mL/minute/1.73m2 not on hemodialysis, or with Child-Pugh class B liver impairment, decrease dosage to 300 mg b.i.d. Refer to manufacturer's instructions for toxicity related dosage adjustments.

Non-metastatic castration resistant prostate cancer or metastatic castration-sensitive prostate cancer
Adults: 600 mg PO b.i.d. Continue until disease progression or unacceptable toxicity. Patient should also receive a GnRH agonist or antagonist concurrently or have had a bilateral orchiectomy.

Metastatic castration-sensitive prostate cancer in combination with docetaxel
Adults: 600 mg PO b.i.d. Give first of 6 cycles of docetaxel within 6 weeks after the starting drug. Continue darolutamide until disease progression or unacceptable toxicity, regardless of docetaxel treatment delays, interruptions or discontinuation. Refer to docetaxel prescribing information for further information. Patient should also receive a GnRH agonist or antagonist concurrently or have had a bilateral orchiectomy.

ADVERSE REACTIONS

CNS: asthenia, fatigue.
CV: arrhythmia, hemorrhage, HF, HTN, ischemic heart disease.
GI: constipation, decreased appetite.
GU: hematuria, urinary retention, UTI.
Hematologic: anemia, febrile neutropenia, lymphocytopenia, neutropenia.
Hepatic: increased AST, ALT, and bilirubin levels.
Metabolic: hyperglycemia, hypocalcemia, weight gain.
Musculoskeletal: fracture, limb pain, pain.
Respiratory: pneumonia.
Skin: rash, eczema, skin exfoliation.
Other: sepsis, spinal cord compression.

INTERACTIONS

Drug-drug. BCRP substrates (rosuvastatin). May increase substrate level. Avoid use together, if possible. If used together, monitor more frequently for adverse reactions and consider substrate dose reduction.
Combined P-gp and strong CYP3A4 Inhibitors (eitraconazole). May increase darolutamide level. Monitor for adverse reactions and adjust darolutamide dose as needed.
Combined P-gp and strong or moderate CYP3A4 inducers (rifampicin). May decrease darolutamide level. Avoid use together.
Organic anion transporting polypeptides (OATP) 1B1 and 1B3 substrates (rosuvastatin). May increase OATP1B1 or OATP1B3 substrate level. If used together, monitor more frequently for adverse reactions and consider substrate dose reduction.


CONTRAINDICATIONS AND CAUTIONS

  • Use cautiously in patients with seizures, or kidney or liver impairment. Use in patients with eGFR 15 mL/minute/1.73m2 or less, or Child class C liver impairment haven't been established.
  • Drug may cause seizures. It is unknown whether anti-epileptic medications will prevent seizures in patients taking drug.
  • Use cautiously in those with CV risk factors (HTN, diabetes, or dyslipidemia). Drug may cause ischemic heart disease.
  • Safety and effectiveness in women and children haven't been established.
  • Dialyzable drug: Unknown.


PREGNANCY-LACTATION-REPRODUCTION

  • Drug may cause fetal harm and pregnancy loss. Drug isn't indicated for use in females.
  • Males with female partners of childbearing potential should use effective contraception during therapy and for 1 week after final dose.
  • Drug may impair male fertility.

Reactions in bold italics are life-threatening.

Released: October 2025

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New FDA Drug Approvals Archive

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
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