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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

Akeega FDA Approved

A fixed-dose combination of 50mg or 100mg of niraparib and 500mg of abiraterone, Akeega tablets was approved by the U.S. Food and Drug Administration (FDA) on Aug. 11, 2023. Along with prednisone, Akeega is indicated for treating adult patients who have metastatic castration-resistant prostate cancer (mCRPC) that has deleterious or suspected deleterious BRCA gene mutations (BRCAm) as determined by a diagnostic test. A gonadotropin-releasing hormone (GnRH) analog, such as leuprolide, also should be used for patients who have not had a bilateral orchiectomy (surgical castration). The recommended dose is niraparib 200mg/abiraterone 1,000mg (two higher strength tablets) taken once a day at least two hours after and one hour before eating any food. Marketed under the brand name, Zejula® (GSK), niraparib is a PARP inhibitor that destroys cancer cells or limits their growth by interfering with an enzyme cancer cells need to repair DNA. Abiraterone, available as the brands Zytiga® (Janssen) and Yonsa® (Sun Pharma) and as generics, blocks testosterone production. Between 10% and 15% of the estimated 288,000 new cases of prostate cancer diagnosed in the U.S. each year are believed to have BRCA mutations. At a wholesale acquisition cost (WAC) of $18,750/month, Janssen will launch Akeega in the U.S. around Sep. 15, 2023. Two other PARP inhibitors — Lynparza® (olaparib – AstraZeneca/Merck) and Talzenna® (talazoparib – Pfizer) — currently are FDA approved to treat mCRPC with BRCA mutations. Each also is used in combination with other drugs. Here is the prescribing information for Akeega.

FDA Approves Hepzato Kit for Hepatic-Dominant Metastatic Uveal Melanoma

Delcath Systems received FDA approval on Aug. 14, 2023, for Hepzato Kit, a new combination and delivery system for the chemotherapy (chemo) drug, melphalan. It is indicated for treating adults who have liver metastases from uveal melanoma (mUM), a rare cancer of the eyes that affects only about 2,000 Americans annually. Nearly all cases of mUM involve the liver and many patients who have it die from liver failure. For treatment, Hepzato is given by 30-minute long infusions into the hepatic artery at a dose of 3mg/kg of ideal body weight up to 220mg/dose. Patients must weigh at least 35kg (77 pounds) and be within defined ranges of certain blood components. Each dose should be followed by a 30-minute washout period and three days or longer of observation to ensure that no serious adverse effects occur. Patients who have brain metastases, liver failure, and/or some heart conditions should not be treated with Hepzato. Treatment with some medications, including anticoagulants and some heart drugs, should be suspended before the infusion. Because it may cause potentially fatal adverse effects, such as blood cell abnormalities, blood clots, hemorrhages, liver damage, and myelosuppression; Hepzato has a boxed warning and a risk evaluation and mitigation strategy (REMS). It can be administered only by healthcare providers who are trained and certified in its use and only in facilities that are certified, equipped, and staffed to give it. Infusions are spaced between six and eight weeks apart for no more than six doses. In a clinical trial that included 51 patients who had not been given any treatment and 40 previously-treated patients, Hepzato treatment resulted in responses, that lasted an average of 14 months, for about one-third of participants. Launch is expected in the fourth quarter of 2023, but pricing is not yet known. For its full prescribing information, look here.

New Indication for Daxxify Daxxify® (daxibotulinumtoxinA-lanm – Revance Therapeutics) injection was given a new FDA approval on Aug. 11, 2023. It now is indicated to treat adults who have muscle spasms caused by cervical (neck muscle) dystonia (uncontrollable muscle contractions), which also may be called spasmodic torticollis. Up to one-quarter of the 60,000 American patients estimated to have cervical dystonia have a family history of the condition as shown by mutations in a few different genes that are associated with it. Sometimes resulting from an injury, cervical dystonia more often has no apparent cause. It makes the head lean to one side or twist away from the front of the body. The neck may be bent at unusual angles and the shoulders may raise close to the ears. Although they progress slowly, symptoms may change erratically – eventually spreading to the face, arms or shoulders for around 35% of patients. Most patients are diagnosed between their 40s and 60s, with roughly twice as many women affected as men. To treat it, the recommended dose of Daxxify is 125 units to 250 units divided into parts and injected intramuscularly (IM) into the muscles that are involved. Treatments should be spaced at least three months apart. Four other botulinum toxins that also are approved by the FDA to treat cervical dystonia are Botox® (onabotulinumtoxinA), Dysport® (abobotulinumtoxinA), Myobloc® (rimabotulinumtoxinB) and Xeomin® (incobotulinumtoxinA). All are branded products and none can be substituted for any other one. All botulinum toxin products have Medication Guides and boxed warnings that they potentially may cause widespread side effects, such as muscle weakness and vision changes if they migrate away from the areas where they are injected. Rarely, serious breathing or swallowing problems can occur. Side effects may not be evident until several weeks after the product has been injected. Previously, Daxxify had been approved only for one cosmetic use — temporary smoothing of glabellar (frown) lines. Click here for its revised prescribing information.