Erivedge Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Erivedge Indications
Indications
Erivedge Dosage and Administration
Adult
Children
Erivedge Contraindications
Not Applicable
Erivedge Boxed Warnings
Boxed Warning
Erivedge Warnings/Precautions
Warnings/Precautions
Risk of embryo-fetal death or severe birth defects in pregnant women. Verify pregnancy status within 7 days prior to initiating therapy. Advise females of reproductive potential to use effective contraception during therapy and for 24 months after final dose; male patients should use condoms (even after a vasectomy) during and for 3 months after final dose. Advise patients not to donate blood or blood products during therapy and for 24 months after final dose. Advise male patients not to donate semen during and for 3 months after final dose. Permanently discontinue if severe cutaneous adverse reactions occur (eg, SJS, TEN, DRESS). Obtain baseline serum CPK and creatinine levels, and as clinically indicated. Based on severity, interrupt dose or discontinue if musculoskeletal adverse reactions occur or serum CPK elevation. Premature fusion of the epiphyses (in pediatrics, if exposed). Pregnancy: avoid. Nursing mothers: not recommended (during and for 24 months after final dose).
Erivedge Pharmacokinetics
Absorption
Single dose absolute bioavailability: 32%.
Distribution
Volume of distribution: ranges from 16.4–26.6 L.
Plasma protein bound: >99%.
Elimination
Fecal (82%), renal (4.4%).
Half-life: 4 days (after continuous once-daily dosing); 12 days (after a single dose).
Erivedge Interactions
Not Applicable
Erivedge Adverse Reactions
Adverse Reactions
Muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, vomiting, decreased appetite, constipation, arthralgias, ageusia; amenorrhea.
Erivedge Clinical Trials
See Literature
Erivedge Note
Notes
Erivedge Patient Counseling
See Literature
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