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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 5 | Issue 17
October 1, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

Momelotinib Approved to Treat Myelofibrosis in Patients with Anemia

On September 15, 2023, the U.S. Food and Drug Administration (FDA) approved Ojjaara™ (momelotinib) for the treatment of intermediate or high-risk myelofibrosis in adult patients with anemia. Myelofibrosis is a rare blood cancer associated with built up scar tissue in the spongy marrow inside of the bone, causing anemia, fatigue, weakness, bone pain and swelling of the liver and spleen. Most patients diagnosed with myelofibrosis develop anemia over the course of their disease that requires blood transfusions. Ojjaara™ is the first drug approved for use in newly diagnosed or previously treated myelofibrosis. Ojjaara™ inhibits Janus kinase (JAK) 1, JAK 2 and activin A receptor type 1 (ACRV1) to improve anemia, enlarged spleen (splenomegaly) and the symptoms associated with myelofibrosis. It is available as a once-daily oral tablet. In a double-blind, active-controlled clinical trial, 195 symptomatic and anemic patients were randomized to receive either Ojjaara™ or danazol, an oral steroid, for 24 weeks. A greater proportion of patients in the Ojjaara™ group reported a 50% or greater reduction in total symptom score (TSS) compared to those in the danazol group. The most common adverse effects seen in clinical trials include low platelet count, bleeding, bacterial infection, fatigue, dizziness, diarrhea and nausea. Ojjaara™ was approved under FDA Orphan Drug designation.

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Drug Safety

Voluntary Recall of Cyclosporine Oral Solution

Dr. Novartis announced a voluntary recall of Sandimmune® Oral Solution (cyclosporine oral solution, USP on September 11, 2023. One lot of Sandimmune® 100 mg/mL Oral Solution, packaged in 50 mL bottles, was recalled due to crystal formation in some containers. This crystallization could cause the active ingredient to be distributed unevenly in the solution, resulting in doses that are too high or too low. Sandimmune® is indicated for the prevention of organ rejection in kidney, liver and heart transplants. In this population, under-dosing of Sandimmune® may result in graft rejection and loss. Repeated over-dosing may lead to cyclosporine toxicity.

The recalled lot has an associated lot number of FX001691 and expiration date of December 2025. It was distributed to wholesalers across the U.S. beginning in April 2023. Novartis is sending letters to distributors and health care providers to notify them of this recall, and they are arranging for the return of the recalled lot from distributors, retailers and consumers. Additionally, consumers with bottles of the recalled lot of Sandimmune® should contact their health care provider to inform them. To date, there have been no adverse events reported associated with this recall. Patients experiencing any adverse events related to the recall are advised to contact their physician or health care provider and to report the event to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Review of Cold Medicine’s Efficacy

On September 11 and 12, the FDA Drug Advisory Committee reviewed the effectiveness of oral phenylephrine, a commonly used over-the-counter medication to treat nasal congestion associated with colds and infections. Products may contain this ingredient alone or in combination with other medications, such as pain relievers, antihistamines and/or cough suppressants. Common drug products containing phenylephrine include Vicks® Nyquil™, Sudafed PE® and Benadryl® Allergy Plus Congestion. Before this review, oral phenylephrine was thought to be a safe and effective decongestant. Newly available data has shown that approved doses of oral phenylephrine are still considered safe, but they are not effective in the treatment of congestion from infection or cold. Going into the fall and winter, it becomes more common to experience colds, infections and illnesses. Due to the latest finding, patients may need to consider alternative ways to manage nasal congestion during cough and cold season.

Although oral phenylephrine is not recommended, other over-the-counter treatment options will remain accessible to patients. Phenylephrine nasal spray is still widely available and supported by the FDA as an effective form of treatment. Nasal sprays containing phenylephrine or oxymetazoline are very effective medications that decrease congestion for up to 3 days of use. Patients are advised to use these medications as directed to avoid the risk of rebound congestion, which is inflammation of the mucosal layer of the nose caused by overuse of decongestant nasal sprays. Steroid nasal sprays, like Flonase® (fluticasone) or Nasonex™ (mometasone), can decrease congestion, itching and sneezing and can be used for a longer time than decongestant nasal sprays.

There are also still many oral, over-the-counter, options available for patients to take as well.  Antihistamines, such as Claritin® (loratadine), Zyrtec® (cetirizine), Allegra® (fexofenadine) and Benadryl® (diphenhydramine), may help relieve congestion by reducing the amount of histamine that your body produces and can cause nasal inflammation and allergy symptoms. Among these options, diphenhydramine may cause more drowsiness than the others. Pseudoephedrine is an additional non-prescription medication with very efficacious decongestant effects. While patients do not need a prescription to acquire pseudoephedrine, they must purchase it from a pharmacy and only in a limited quantity. Like phenylephrine, pseudoephedrine is available on its own or in combination with pain relievers and/or other ingredients to manage cough and cold symptoms. Patients with high blood pressure should discuss with their pharmacist if pseudoephedrine is an appropriate treatment option for them.

In addition, there are drug-free options for relieving nasal congestion. Saline rinses, sprays and drops and neti pots can be used by patients to clear out congestion caused by pollen, mucus or debris within the nasal cavity. Humidifiers can also be used to loosen congestion and are appropriate for patients of any age. With a variety of treatments available, patients should consult with their physician or pharmacist to discuss which options are best for their needs.

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FDA Approvals

New FDA Approvals

New Drug: Aphexda® (motixafortide)

Subcutaneous injection approved for use with filgrastim in patients with multiple myeloma to increase the number of stem cells in the blood before they are collected for future stem cell transplant. [09/08/23 – ORPHAN DRUG – BIOLINERX, LTD]

New Dosage Form: Melphalan hydrochloride 

Intravenous injection approved for palliative treatment in patients with multiple myeloma who are unable to use oral therapy. [08/18/23 – APOTEX]

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New Generics

New Generics Entering the Marketplace

Alphagan P®  (brimonidine tartrate)

Indication: Used in the reduction of elevated pressure in the eye in patients with ocular hypertension or open-angle glaucoma.

Dosage Form/Strength: 0.1% ophthalmic solution

Average Wholesale Price (AWP): Generic = $443 | Brand = $466