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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

Onyda XR Approved

The U.S. Food and Drug Administration (FDA) approved Tris Pharma’s Onyda XR extended-release oral suspension, a new dosage form for clonidine, on May 24, 2024. It is indicated to treat pediatric patients as young as six years old who have attention deficit hyperactivity disorder (ADHD). Taken once a day at bedtime, the beginning dose is 0.1mg (1mL), which can be increased, if needed, by 0.1mg at weekly intervals to as much as 0.4mg/day. Clonidine is a centrally acting alpha2-adrenergic agonist first approved in the 1970s to treat hypertension. In 2010, Kapvay® (clonidine) extended-release tablets were FDA-approved for ADHD. Onyda XR is not interchangeable with Kapvay or any other clonidine product. In contrast to central nervous system (CNS) stimulant medications, such as methylphenidate, that also treat ADHD, clonidine is not a stimulant or a controlled substance. Onyda XR can be used in combination with a stimulant, though, or by itself. Launch for Onyda XR is planned for the second half of 2024, but its pricing is unavailable. Here is its prescribing information. 

Additional Indication for Breyanzi

Breyanzi® (lisocabtagene maraleucel – Bristol Myers Squibb) was FDA approved on May 30, 2024, to treat adults who have mantle cell lymphoma (MCL) that has returned or resists treatment after at least two previous drug therapies, including a Bruton kinase inhibitor (BKI). In the decisive clinical trial, 85% of the 68 treated patients responded to therapy within an average of one month and for an average length of over 13 months.  Breyanzi is an autologous chimeric antigen receptor (CAR-T) modified T-cell therapy that targets the CD19 antigen expressed by many B-cell malignancies. Doses are tailored to each patient using their own genetically modified T-cells, engineered to attack cancer cells once returned to the patient as one intravenous (IV) infusion. Initially, FDA-approved in February 2021, it also treats adults who have relapsed or refractory diffuse large B-cell lymphomas (r/r DLBCL) that have not responded to at least one other type of systemic treatment. Additionally, it has Accelerated Approval as third- or later-line therapy for adults who have r/r chronic lymphocytic leukemia (r/r CLL), small lymphocytic lymphoma (r/r SLL), or follicular lymphoma (r/r FL). Further documentation of its effectiveness and safety for treating its Accelerated Approval indications will be needed for full FDA approvals. Labeling for Breyanzi carries a boxed warning and it has a Medication Guide due to potentially life-threatening cytokine release syndrome (CRS), neurological events, and T-cell cancers that may be related to its use. It is available only through hospitals and associated outpatient clinics that are certified through a Risk Evaluation and Mitigation Strategy (REMS) program. Its current prescribing information is here.

Pediatric Indication Extended for Retevmo

The FDA used Priority Review to expand its pediatric Accelerated Approvals for Retevmo (selpercatinib – Eli Lilly) on May 29, 2024. A novel tyrosine kinase inhibitor (TKI) with Orphan Drug status, Retevmo is specific to mutations of the rearranged during transfection (RET) gene. Originally, it was granted the FDA’s Accelerated Approval in May 2020 for patients at least 12 years old who require systemic treatment for RET+ metastatic medullary thyroid cancer (MTC) or advanced RET+ thyroid cancer that cannot be managed by radioactive iodine (RAI). Later, it received Accelerated Approval for locally advanced or metastatic solid tumors that test positive for a RET gene fusion and that worsen during or after systemic treatment or that cannot be treated in other ways. Now, those indications include patients as young as two years old. In a phase I/II clinical trial, 12 of the 25 children and teens who were treated with Retevmo had a response and 11 of the responders remained in remission at one year. Doses, which are taken orally two times a day, depend on the child’s body surface area (BSA) until they are 12 years old when doses switch to being weight-based for teens and adults. Retevmo has full FDA approval as a second-line treatment for adults who have metastatic RET+ non-small lung cancer (NSCLC). Because Accelerated Approval for Retevmo’s use to treat thyroid cancers and solid tumors is based on unfinished clinical studies, additional positive results from the continuing trials will be needed before the FDA fully approves those indications. Prescribing information has been updated here.

New Strengths for Austedo XR

Teva Pharmaceuticals received FDA approval on May 29, 2024, for additional strengths of Austedo® XR (deutetrabenazine) extended-release tablets. It is approved to treat adults who have either tardive dyskinesia (TD) or chorea (spontaneous muscle spasms) that accompanies Huntington’s disease. Also causing uncontrollable movements of the face and body, TD results from prolonged use of certain drugs, including some anti-nausea agents and antipsychotics, which may interfere with dopamine activity. By inhibiting vesicular monoamine transporter 2 (VMAT2), Austedo XR is believed to decrease the amounts of monoamines, such as dopamine, at nerve receptors. It is taken once a day with or without food. Doses begin at 12mg and increase in 6mg increments once a week, if needed, to a maximum of 48mg/day. Originally available as 6mg, 12mg, and 24mg tablets, Austedo XR now has 30mg, 36mg, 42mg, and 48mg options, as well; decreasing the need to take multiple tablets for higher doses. Its labeling includes a boxed warning because taking it raises the chances that patients who have Huntington’s disease may become depressed or suicidal. Other side effects may include diarrhea, dry mouth, sleep disturbances, and upper respiratory tract infections. Look here for revised prescribing information.

Maximum Dose Increased for Firdapse

The recommended highest adult dose for Catalyst Pharmaceuticals’ Firdapse® (amifampridine) tablets was increased by the FDA on May 29, 2024. FDA-approved for adults in 2018 and for children aged six years and older in 2022, Firdapse is indicated to treat Lambert-Eaton myasthenic syndrome (LEMS), an autoimmune disease that interrupts the flow of nerve impulses to muscles. One result is fatigue and weakness, especially in the legs. LEMS has been diagnosed in only about 400 Americans, mostly adults. Firdapse blocks potassium channels to increase the production of the neurotransmitter, acetylcholine, which enhances nerve transmissions. All adults and children who weigh 45kg (about 100 pounds) or more begin at a total dose of 15mg to 30mg per day. If lower doses are not effective, they can be increased by 5mg/day every three or four days, to a new upper limit of 100mg daily. For children weighing less than 45kg, the maximum dose remains at 40mg/day. All daily totals should be divided into three or four equal parts. Firdapse should not be used for patients who have or have ever had seizures. The new prescribing information will be posted here.