Monograph Details
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Neoplasms
> Hormones and antagonists
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PLENAXIS |
| Manufacturer |
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Praecis Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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GnRH antagonist. |
| Generic Name |
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Abarelix 100mg/vial; pwd for IM inj after reconstitution; preservative-free. |
| Indications |
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Palliative treatment of advanced symptomatic prostate cancer in select patients (see literature). |
| Children |
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Not applicable. |
| Adults |
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Give by IM inj in buttock. 100mg on days 1, 15, 29, and then once every 4 weeks. |
| Contraindications |
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Pregnancy (Cat.X). Nursing mothers. Not for use in women or children. |
| Precautions |
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QT interval prolongation (baseline QTc >450msec). Monitor for allergic reaction for at least 30 minutes after each dose. Patients >225 lbs. Obtain serum total testosterone before dosing on day 29 and then every 8 weeks. Monitor liver function at baseline before treatment then periodically; consider monitoring serum PSA. |
| Interactions |
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Caution with Class IA antiarrhythmics (eg, quinidine, procainamide) or Class III antiarrhythmics (eg, amiodarone, sotalol) and other drugs that can cause QT interval prolongation. |
| Adverse Reactions |
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Systemic allergic reactions (risk increases with continued dosing), hot flushes, sleep disturbances, pain, gynecomastia, mastodynia, constipation, peripheral edema, dizziness, headache, upper respiratory tract infection, GI upset, dysuria, fatigue, micturition frequency, urinary retention, UTI, increased serum transaminases and triglycerides, decreased hemoglobin and bone mineral density, QT prolongation. |
| Extra Text |
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Note: Available only to physicians enrolled in Plenaxis Plus Prescribing Program. To enroll call (866) 753-6294. |
| How Supplied |
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Single-dose vial—1 (w. diluent and supplies) |
| Additional Resources |
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• Related Prescribing Note |
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