New Dosage Form for Risperidone

Rykindo^®, an extended-release injectable formulation of the atypical antipsychotic drug, risperidone, was approved by the U.S. Food and Drug Administration (FDA) on Jan. 13, 2023. Indicated for treating adults who have schizophrenia, it also is approved either by itself or along with lithium or valproate as maintenance therapy for adults who have bipolar I disorder. The recommended dose for treating both conditions is one injection given by a healthcare provider into the muscles of the buttocks once every two weeks. Beginning at 25mg/injection, doses can be increased to 37.5mg/injection after at least four weeks and then to the highest recommended dose, 50mg/injection, if needed, after four or more additional weeks. On the same day as their first shot of Rykindo, patients who have not used an oral risperidone product previously should start a seven-day course of oral risperidone. A boxed warning on its labeling reminds patients and prescribers that no atypical antipsychotic should be used to manage psychoses associated with dementia in elderly patients because their chances of death are increased. The manufacturer, Luye Pharma, has not announced its launch or pricing plans for Rykindo. Risperidone also is marketed in the U.S. as Risperdal^® (Janssen Pharmaceuticals)/generic oral tablets, generic orally disintegrating tablets, and Risperdal^®/generics oral solution. Two brand-only extended-release injectable products, once-every-two-weeks Risperdal Consta^® powder for suspension and once-every-month Perseris^® (Indivior) suspension, also are available in the United States. Here is prescribing information for Rykindo.

New Indication for Tukysa

Seagen received the FDA’s Accelerated Approval for a new indication for its tyrosine kinase inhibitor, Tukysa^® (tucatinib) tablets, on Jan. 19, 2023. The new approval is for second-line or later use in combination with trastuzumab (Herceptin^®/biosimilars) injection for treating adults who have advanced colorectal cancer (CRC) that is confirmed to be both RAS wild-type and human epidermal growth factor receptor 2 positive (HER2+). The two-drug regimen will be used when CRC has worsened despite prior chemotherapy (chemo) that includes fluoropyrimidine, oxaliplatin, and irinotecan. In a clinical trial, more than one-third of patients taking Tukysa and using trastuzumab had at least some response to therapy, with the average length of response slightly over one year. Some patients experienced severe diarrhea and/or liver damage, so the patient’s hydration status should be watched carefully and liver enzymes should be checked before treatment begins and about every three weeks during therapy. Women of reproductive age should use effective forms of contraception while taking Tukysa because it can injure an unborn baby. The recommended dose is 300mg (two 150mg tablets) twice a day. The first treatment specifically approved for HER2+ colorectal cancer, Tukysa was given the FDA’s Breakthrough Therapy designation and it was approved under a Priority Review. The approval is based on interim results from a clinical study, however, so further proof of the therapy’s advantages for patients is needed for full FDA approval. Tukysa initially was FDA-approved, along with trastuzumab and capecitabine, in April 2020 for treating HER2+ breast cancer. Look here for Tukysa’s complete prescribing information.

Brukinsa Receives New Indication On Jan. 19, 2023, the FDA approved a new use for Brukinsa^® (zanubrutinib – BeiGene) capsules. It now is indicated for treating adults who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). A Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa blocks the activity of an enzyme needed by cancer to multiply and spread. In two clinical studies for CLL and SLL, patients taking Brukinsa had comparable results to those using current standards of care. In one study, cancer worsened for 11% of patients taking Brukinsa versus 25% of those on an intravenous (IV) infusion regimen of bendamustine and rituximab. In the second study, the overall response rate (ORR) was 80% for Brukinsa as opposed to 73% for participants who took another oral BTK inhibitor, Imbruvica® (ibrutinib – Pharmacyclics/Janssen). Approved in the U.S. to treat mantle cell lymphoma (MCL) in 2019, Brukinsa’s other approvals are to treat Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma (MZL). For all its indications, its recommended daily dose is 320mg (two capsules), which can be taken together as one dose or divided into two separate doses. Its revised prescribing information is here.