Pharmacy Bulletin

Pharmacy Bulletin

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

VativoRx Bottle update

New Herceptin Biosimilar Approved

Accord BioPharma received U.S. Food and Drug Administration (FDA) approval on April 25, 2024, for Hercessi (trastuzumab-strf) injection, a biosimilar for Genentech’s Herceptin® (trastuzumab). Like Herceptin and its other FDA-approved biosimilars, Hercessi is infused intravenously (IV) to treat breast cancers and metastatic stomach cancers (gastric or gastroesophageal junction adenocarcinomas) that overexpress human epidermal growth factor receptor 2 (HER2+). Dosing and scheduling vary depending on the kind and stage of the cancer being treated. Hercessi may be used alone or combined with chemotherapy (chemo). Other biosimilars for Herceptin have been available in the United States for at least the last four years. They are Herzuma® (trastuzumab-pkrb – Teva Pharmaceuticals/Celltrion Healthcare), Kanjinti (trastuzumab-anns – Amgen/Allergan), Ogivri (trastuzumab-dkst – Mylan/Biocon Biologics), Ontruzant® (trastuzumab-dttb – Merck) and Trazimera (trastuzumab-qyyp – Pfizer). None of the biosimilars can be substituted for Herceptin, each other or Kadcyla® (adotrastuzumab emtansine), Genentech’s antibody-drug conjugate. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. Hercessi will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information for Hercessi may be found here.

New Formulation for Cyltezo

A new formulation of Cyltezo® (adalimumab-adbm), Boehringer Ingelheim’s biosimilar to Humira® (adalimumab), was FDA approved on April 29, 2024. A high-concentration (100mg/mL), citrate-free version, it is injected subcutaneously (SC), typically once every two weeks. It and its original 50mg/mL dose are indicated for treating adults who have ankylosing spondylitis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA), ulcerative colitis (UC) and uveitis. They also have FDA approvals to treat pediatric and adult Crohn’s disease and polyarticular juvenile idiopathic arthritis (PJIA). Although a launch date for the higher strength is not yet available, it will be dispensed in single-dose prefilled syringes and pen devices, as is the lower strength. All drugs that block the activity of tumor necrosis factor (TNF), including Humira and its biosimilars, carry boxed warnings outlining the increased risks of cancer and serious infections that may be associated with their use. Prospective patients also should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Click here for Cyltezo’s full prescribing information.

Libervant Receives FDA Approval

Aquestive Therapeutics’ new dosage form for diazepam, Libervantbuccal film strips, was approved by the FDA on April 26, 2024. It is indicated for acute treatment of children between the ages of two years old and five years old who have epilepsy and who experience atypical episodes, such as seizure clusters, beyond their usual seizure patterns. Supplied in individual packets, Libervant is applied to the inside surface of the child’s cheek and allowed to melt. The strength of the dose depends on the weight of the child. If needed, one additional strip may be used four hours or longer after a dose. No more than two doses should be used for each episode, Libervant should not be given more than five times per month and at least five days should be allowed between uses. A boxed warning is required on its label because using opioids along with it or any other drug in the benzodiazepine class may cause respiratory depression, coma, and death. All patients should be watched for signs of respiratory and/or cardiac distress after receiving a dose of Libervant. Additionally, as a C-IV controlled substance, it has the potential for abuse, addiction, or misuse. It will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Here is its prescribing information.

Full Approval for Tivdak

Pending results from additional clinical testing, Tivdak® (tisotumab vedotin-tftv) received Accelerated Approval from the FDA in September 2021. On April 29, 2024, positive results from the research allowed the FDA to award full approval. The antibody-drug conjugate (ADC) treats adults who have recurrent or metastatic cervical cancer with disease progression during or after chemo. In the trial, the risk of death was 30% less for patients using Tivdak compared with those using chemo and the average length of overall survival (OS) was two months longer (11.5 months vs. 9.5 months, respectively). Tivdak is given by IV infusion at a recommended dose of 2mg/kg (with a maximum of 200mg) over 30 minutes once every three weeks. A boxed warning cautions that using it may cause vision loss or corneal ulceration. Patients should have an eye exam before starting treatment, before each of the first nine doses, and then periodically. In addition, a corticosteroid, vasoconstriction, and lubricating eye drops should be used in each eye before infusions and for additional periods after each treatment. Other potentially severe side effects may include hemorrhaging, peripheral neuropathy, pneumonitis, and serious skin reactions. Tivdak is owned jointly by Genmab and Pfizer, which bought Genmab’s original partner, Seagen, in December 2023. For complete prescribing information, go here.

New Dosage Form for Ingrezza

On April 29, 2024, the FDA approved Ingrezza® (valbenazine) Sprinkle Capsules. A selective vesicular monoamine transporter 2 (VMAT2) inhibitor, it is indicated to treat adults who have tardive dyskinesia (TD) and chorea caused by Huntington’s disease (HD). Available in the same strengths (40mg, 60mg, and 80mg) as Ingrezza capsules, the sprinkles are mixed with about one tablespoonful of a soft cool, food, such as yogurt, and consumed within two hours once a day. Labeling for Ingrezza has a boxed warning that taking it may raise the risk of depression and suicidal thoughts/actions for patients who have HD. Two other VMAT2 inhibitors, Austedo™/XR(deutetrabenzine/extended-release – Teva) tablets, and Xenazine® (tetrabenazine – Lundbeck, generics) tablets, also are FDA-approved for treating chorea related to HD, and Austedo indicates TD, as well. Neither is available in a sprinkle or oral liquid dosage form. Ingrezza’s manufacturer, Neurocrine Biosciences, has not announced its plans for pricing and marketing the sprinkles. Ingrezza’s revised prescribing information is here.