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General Discussions

June Adverse Events Report: FDA Labeling Changes

By Anita Shaffer


Warnings and Precautions updated:

  • Embryo-fetal toxicity: Advise females of reproductive potential to use effective contraceptive measures to prevent pregnancy while being treated with bosutinib and for at least 30 days after the final dose.

Adverse Reactions added:

  • Skin and subcutaneous tissue disorders (postmarketing experience): Stevens-Johnson syndrome


Adverse Reactions updated:

  • Musculoskeletal and connective tissue disorders (postmarketing experience): musculoskeletal pain upon treatment discontinuation, including myalgia, pain in extremities, arthralgia, bone pain.
  • Infections (postmarketing experience): hepatitis B virus reactivation
  • Acute lymphoblastic leukemia: Superficial edema was a common finding in all studies and was described primarily as periorbital or lower limb edemas. These edemas were reported as grade 3/4 events in 6.3% of the patients and may be managed with diuretics, other supportive measures or, in some patients, by reducing the dose of imatinib.


Adverse Reactions added:

  • Skin and subcutaneous tissue disorders: nail disorders including paronychia; severe cutaneous adverse skin reactions, including Stevens-Johnson syndrome and toxic epidural necrolysis.
  • Cardiac disorders: ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolongation.

Patient Counseling Information expanded:

  • Severe skin reactions: lapatinib may cause severe skin reactions. Advise patients to inform their healthcare provider immediately if symptoms develop, including skin rash; red skin; blistering of the lips, eyes, or mouth; peeling of the skin; fever; or any combination of these.


Drug Interactions added: CYP3A4

  • CYP3A4 inhibitors: Vemurafenib is a substrate of CYP3A4; therefore, coadministration of strong CYP3A4 inhibitors may increase vemurafenib plasma concentrations and may lead to increased toxicity.
  • CYP3A4 inducers: Coadministration of vemurafenib with rifampin, a strong CYP-3A4 inducer, decreased vemurafenib plasma concentrations and may result in decreased efficacy. Avoid coadministration of vemurafenib with strong CYP3A4 in- ducers (eg, phenytoin, carbamazepine, rifampin), and replace these drugs with alternative drugs when possible. If coadministration of a strong CYP3A4 inducer is unavoidable, increase the dose of vemurafenib by 240 mg (1 tablet) as tolerated.

Use in Specific Populations: updated

  • Females of reproductive potential: Based on its mechanism of action, vemurafenib can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with vemurafenib and for 2 weeks after the final dose.
  • Risk summary: There are no available data on the use of vemurafenib in pregnant women to determine the drug-associated risk; however, placental transfer of vemurafenib to a fetus has been reported.
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