New FDA Drug Approvals - January 2022


atogepant

Qulipta

Pharmaceutical company: AbbVie

Pharmacologic classification:Calcitonin gene-related peptide receptor antagonist

Therapeutic classification:Antimigraine drug

AVAILABLE FORMS

Tablets: 10 mg; 30 mg; 60 mg

INDICATIONS AND DOSAGES

Prevention of episodic migraine headaches

Adults: 1 tablet PO once daily.

Adjust-a-dose: If taking with a strong CYP3A4 inhibitor, the recommended dose is 10 mg PO once daily. If taking with a strong or moderate CYP3A4 inducer, the recommended dose is 30 mg or 60 mg PO once daily. If taking with an OATP inhibitor, the recommended dose is 10 mg or 30 mg PO once daily. If severe renal impairment or end-stage renal disease (creatinine clearance less than 30 mL/min), the recommended dose is 10 mg PO once daily.

CONTRAINDICATIONS AND CAUTIONS

  • Avoid use in patients with severe hepatic impairment (Child-Pugh class C).
  • Use cautiously in older adults. Initiate therapy at lowest dose.
  • Safety and effectiveness in children haven’t been determined.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • It isn’t known if this drug causes fetal harm. Use during pregnancy only if clearly indicated and the benefit outweighs the fetal risk. Women with migraine headaches may be at increased risk for preeclampsia and gestational hypertension.
  • It isn’t known if this drug appears in human milk. Use cautiously in women who are breastfeeding.

INTERACTIONS

Drug-drug. OATP inhibitors (cyclosporine, rifampin): May increase level of atogepant. Adjust atogepant dose.

Strong or moderate CYP3A4 inducers (carbamazepine, efavirenz, etravirine, rifampin, phenytoin): May decrease level of atogepant. Adjust atogepant dose.

Strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole): May increase level of atogepant. Adjust atogepant dose.

Drug-herb. St. John’s wort: May decrease level of atogepant. Adjust atogepant dose.

ADVERSE REACTIONS

CNS: fatigue, somnolence.

GI: nausea, constipation, decreased appetite.

Hepatic: increased transaminase levels.

Metabolic: weight loss.

Reactions in bold italics are life-threatening.

Released: January 2022
Nursing Drug Handbook
© 2022 Wolters Kluwer


 

avacopan

Tavneos

Pharmaceutical company: ChemoCentryx, Inc.

Pharmacologic classification:Complement inhibitor

Therapeutic classification:Immunomodulator

AVAILABLE FORMS

Capsules: 10 mg

INDICATIONS AND DOSAGES

Adjunctive treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including glucocorticoids

Adults: 30 mg PO b.i.d. with food.

Adjust-a-dose: When used with strong CYP3A4 inhibitors, reduce dose to 30 mg once daily. If AST or ALT increase to greater than 3 times the upper limit of normal (ULN), consider pausing avacopan. If AST or ALT increases to greater than 5 times ULN, or AST or ALT increases to 3 times ULN with elevation of bilirubin to more than 2 times ULN, discontinue drug until avacopan-induced liver injury is ruled out.

CONTRAINDICATIONS AND CAUTIONS

  • Contraindicated in patients with serious hypersensitivity reaction to avacopan or to any of its components.
  • May cause serious liver injury, transaminase elevations and hepatobiliary events, including serious and life-threatening events.
  • Not recommended for use in patients with active, untreated, or uncontrolled chronic liver disease (hepatitis B, hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis.
  • Reactivation of latent hepatitis B infection and hypersensitivity reactions, including angioedema can occur.
  • Serious and fatal infections have been reported. Avoid use in patients with an active, serious infection.
  • Use cautiously in patients with chronic or recurrent infection, tuberculosis (TB) exposure, history of serious or opportunistic infections, underlying conditions that predispose them to infection, or who have lived or traveled in areas of endemic TB or mycoses.
  • Safety and effectiveness in children haven’t been established.
  • Dialyzable drug: Unknown.

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate data to inform the use of avacopan during pregnancy or breastfeeding; use only if the benefits outweigh the fetal risk.

INTERACTIONS

Drug-drug. CYP3A4 substrates (midazolam): May increase adverse reactions. Monitor patient closely and consider dose reduction of sensitive CYP3A4 substrates with narrow therapeutic window.

Strong and moderate CYP3A4 inducers (rifampin): May decrease level of avacopan. Avoid use together.

Strong CYP3A4 inhibitors (itraconazole): May increase level of avacopan. Reduce avacopan dose to 30 mg PO once daily.

Drug-herb. St. John’s wort: May decrease level of avacopan. Avoid use together.

ADVERSE REACTIONS

CNS: headache, fatigue, dizziness, paresthesia.

CV: hypertension.

GI: nausea, diarrhea, vomiting, upper abdominal pain.

GU: increase in creatinine.

Hepatic: liver enzyme abnormalities.

Skin: rash.

Other: angioedema.

Reactions in bold italics are life-threatening.

Released: January 2022
Nursing Drug Handbook
© 2022 Wolters Kluwer


 

mobocertinib

Exkivity

Pharmaceutical company: Takeda Pharmaceuticals America

Pharmacologic classification:Kinase inhibitor

Therapeutic classification:Antineoplastic

AVAILABLE FORMS

Capsules: 40 mg

INDICATIONS AND DOSAGES

Locally advanced or metastatic non–small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with progression on or after platinum-based chemotherapy

Adults:160 mg PO daily, until disease progression or unacceptable toxicity.

Adjust-a-dose: See the manufacturer’s information for toxicity-related dose reductions. If use with a concomitant moderate CYP3A inhibitor can’t be avoided, reduce mobocertinib dose by approximately 50% and monitor QTc interval more frequently. After moderate CYP3A inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the drug at the dose prior to CYP3A initiation.

CONTRAINDICATIONS AND CAUTIONS

  • Black Box Warning: This drug can cause life-threatening heart rate-corrected QT (QTc) prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes at baseline and periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation.
  • Black Box Warning: Avoid use of concomitant drugs which are known to prolong the QTc interval and use of strong or moderate CYP3A inhibitors, as these may further prolong the QTc.
  • Black Box Warning: Withhold, dose reduce, or permanently discontinue this drug based on the severity of QTc prolongation.
  • This drug can increase the risk of interstitial lung disease/pneumonitis, which can be fatal.
  • This drug increases the risk of cardiac toxicity, including decreased ejection fraction, cardiomyopathy, and heart failure.
  • This drug may cause diarrhea, leading to dehydration or electrolyte imbalance, with or without renal impairment.
  • Safety and effectiveness of this drug in children haven’t been established.
  • Use cautiously in older adults as there may be a higher incidence and severity of adverse reactions.
  • Recommended dosage hasn’t been determined for patients with severe renal or hepatic impairment.
  • Dialyzable drug: Unlikely.

PREGNANCY-LACTATION-REPRODUCTION

  • This drug may cause fetal harm. Females of reproductive potential must use effective nonhormonal contraception during treatment and for 1 month after the last dose, and males with female partners of reproductive potential must use effective contraception during treatment with and for 1 week after the last dose.
  • Due to the potential for adverse reactions in a child who is breastfed, women should not breastfeed during treatment and for 1 week after the last dose.
  • This drug may impair fertility.

INTERACTIONS

Drug-drug. CYP3A substrates (midazolam): May decrease level of substrate; consider increasing substrate dosage if possible.

Black Box Warning: Drugs that prolong the QTc interval (haloperidol, thioridazine, amiodarone, procainamide, lithium, ciprofloxacin, methadone, SSRIs, tricyclic antidepressants): May significantly increase risk of QTc prolongation; avoid use together. If use together is unavoidable, monitor QTc carefully.

Hormonal contraceptives: May decrease level of contraceptive and cause therapeutic failure. Avoid use together.

Strong and moderate CYP3A inducers (rifampin, efavirenz): May decrease mobocertinib level and antitumor activity; avoid concomitant use.

Black Box Warning: Strong or moderate CYP3A inhibitors (itraconazole, ketoconazole): May increase mobocertinib level; avoid use together. If concomitant use can’t be avoided, reduce mobocertinib dose, monitor the QTc interval more frequently with ECGs, and monitor patients for increased risk of adverse reactions.

Drug-herb. St. John’s wort: May decrease mobocertinib level; discourage use together.

Drug-food. Grapefruit, grapefruit juice: May increase drug level; discourage intake during treatment.

ADVERSE REACTIONS

CNS: headache, fever, fatigue, peripheral neuropathy.

CV: QTc prolongation, atrial fibrillation, hypertension, heart failure, edema.

EENT: ocular toxicity.

GI: diarrheastomatitis, vomiting, decreased appetite, nausea, abdominal pain, gastroesophageal reflux disease, dyspepsia.

GU: acute kidney injury.

Hematologic: leukocytopenia, anemia.

Metabolic: weight loss, increased amylase, increased lipase, hypokalemia, increased creatinine, hypomagnesemia.

Musculoskeletal: pain.

Respiratory: interstitial lung disease, pneumonitis, cough, upper respiratory infection, dyspnea, rhinorrhea, pleural effusion.

Skin: rash, paronychia, dry skin, pruritus, alopecia, hand-foot syndrome.

Reactions in bold italics are life-threatening.

Released: January 2022
Nursing Drug Handbook
© 2022 Wolters Kluwer


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