risks of QT prolongation, Torsades de pointes and sudden death, CAPRELSA is available only through a restricted distribution program called the CAPRELSA REMS Program. Only prescribers and pharmacies certified with the program are able to prescribe and dispense CAPRELSA. To learn about the specific REMS requirements and to enroll in the CAPRELSA REMS Program call 1-800-236–9933 or visit www.caprelsarems.com (5.15).
ADVERSE REACTIONS
The most common adverse drug reactions (>20%) seen with CAPRELSA have been diarrhea, rash, acne, nausea, hypertension, headache, fatigue, decreased appetite and abdominal pain. The most common laboratory abnormalities (>20%) were decreased calcium, increased ALT, and decreased glucose (2.1. 5.2, 5.7, 5.9, 6.1).
To report SUSPECTED ADVERSE REACTIONS, Contact AstraZeneca 1–800–236–9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
The concomitant use of known strong CYP 3A4 inducers may reduce drug levels of CAPRELSA and should be avoided (7.1). No clinically significant drug interaction was shown with CAPRELSA and the potent CYP 3A4 inhibitor, itraconazole (7.2). The administration of CAPRELSA with agents that may prolong the QT interval should be avoided (5.11)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 04/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
BOXED WARNING SECTION
1. INDICATIONS AND USAGE
1.1. Medullary Thyroid Cancer (MTC)
2. DOSAGE AND ADMINISTRATION
2.1 Dosage Adjustment
2.2 Elderly
2.3 Concomitant Strong CYP3A4 Inducers
2.4 Patients With Renal Impairment
2.5 Patients with Hepatic Impairment
3. DOSAGE FORMS & STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 QT Prolongation and Torsades de Pointes
5.2 Skin Reactions and Stevens-Johnson Syndrome
5.3 Interstitial Lung Disease
5.4 Ischemic Cerebrovascular Events
5.5 Hemorrhage
5.6 Heart Failure
5.7 Diarrhea
5.8 Hypothyroidism
5.9 Hypertension
5.10 Reversible posterior leukoencephalopathy syndrome
5.11 Drug Interactions
5.12 Renal Impairment
5.13 Hepatic Impairment
5.14 Use in Pregnancy
5.15 CAPRELSA REMS (Risk eva luation and Mitigation Strategy) Program
6. ADVERSE REACTIONS
6.1. Clinical Studies Experience
7. DRUG INTERACTIONS
7.1 CYP3A4 Inducers
7.2 CYP3A4 Inhibitors
7.3 Drugs that Prolong the QT Interval
8. USE IN SPECIFIC POPULATIONS
8.1. Pregnancy
8.3. Nursing Mothers
8.4. Pediatric Use
8.5. Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10. OVERDOSAGE
11. DESCRIPTION
12. CLINICAL PHARMACOLOGY
12.1. Mechanism of Action
12.3. Pharmacokinetics
12.4 QT Prolongation
13. NONCLINICAL TOXICOLOGY
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2. Animal Pharmacology and/or Toxicology
14. CLINICAL STUDIES
15. REFERENCES
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1. Storage and Handling
17. PATIENT COUNSELING INFORMATION
17.1 QT Interval
17.2 Rash
17.3 Interstitial lung disease
17.4 Diarrhea
17.5 Reversible Posterior Leukoencephalopathy Syndrome
17.6 Pre |
