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Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Generic to Abraxane Launched

On Oct. 11, 2024, Sandoz announced the launch of its generic to Abraxane® (paclitaxel protein-bound particles for injectable suspension – Bristol Myers Squibb) following its Oct. 8, 2024, U.S. Food and Drug Administration (FDA) approval. Paclitaxel protein-bound particles for injectable suspension is a microtubule inhibitor that is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. It will be supplied as a 100mg single-dose vial lyophilized powder for intravenous (IV) infusion. The recommended dose is 260mg/m2 IV over 30 minutes every three weeks. This is the first generic for Abraxane Injectable Suspension and according to the manufacturer, it generated $709 million in 2023 U.S. sales. A link to the prescribing information can be found here.

Lumryz Gets Expanded Indication

The FDA approved an expanded indication for Avadel Pharmaceuticals’ Lumryz® (sodium oxybate) suspension on Oct. 17, 2024. The extended-release oral suspension is now indicated for treating narcolepsy that causes cataplexy (sudden loss of muscle tone, but not of consciousness) or excessive daytime sleepiness (EDS) in patients seven years of age in older. Previously, use was limited to adults. Narcolepsy affects approximately 1 in 2,000 people in the United States, and about 5% of patients are under 18 years of age. A C-III controlled substance, Lumryz carries a boxed warning that drinking alcohol and/or using central nervous system (CNS) depressants (such as opioids, antipsychotics, benzodiazepines or sedating antidepressants) while using it can significantly affect consciousness and can result in severe breathing problems. A Risk Evaluation and Mitigation Strategy (REMS) requires that it be prescribed only by certified providers, dispensed only through certified pharmacies and used only by patients registered with the program. Other sodium oxybate drugs, Xyrem® (sodium oxybate – Jazz Pharmaceuticals/authorized generic) oral solution and Xywav® (calcium, magnesium, potassium and sodium oxybates – Jazz) oral solution, must be taken twice each night – at bedtime and a few hours later – meaning that patients have to wake up for the second dose. Lumryz offers a once-at-bedtime option with packets of 4.5gm, 6gm, 7.5gm or 9gm granules, which are mixed in approximately one-third cup (about 80mL) of water prior to administration.  The dose is taken once after the patient is already in bed and two hours or more after any food is consumed. Here is its prescribing information.