New products: Latest drug releases for June/July

Bimzelx for plaque psoriasis bimekizumab 160 mg/mL solution for subcutaneous (SC) injection; 1 mL autoinjector and 1 mL prefilled syringe, UCB Canada INDICATIONS Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. ACTION A humanized IgG1 monoclonal antibody. It binds and neutralizes interleukin-17A (IL-17A), interleukin-17F (IL-17F) and IL-17AF cytokines. Levels of IL-17A and IL-17F are elevated in several immune-mediated inflammatory diseases. Neutralization of both IL-17A and IL-17F suppresses inflammation (in vitro) to a greater extent than inhibition of IL-17A alone. Mean terminal elimination half-life of bimekizumab is about 23 days. DOSAGE 320 mg (given as two SC injections of 160 mg each) every four weeks for the first 16 weeks, then every eight weeks thereafter. For patients with a body weight ≥ 120 kg who do not achieve a complete skin response by Week 16, an increase to 320 mg every four weeks (after Week 16) may be considered. ADMINISTRATION Administer by SC injection into the thigh, abdomen or upper arm. Do not inject into psoriasis plaques or areas where the skin is tender, bruised, red or indurated. Rotate injection sites. Patients may self-inject (thigh or abdomen only) after proper training in SC injection technique. ADVERSE EFFECTSMOST COMMON: Upper respiratory tract infections (14.5%, most frequently nasopharyngitis), mild/ moderate oral/oropharyngeal candidiasis (7.3%, up to 23.6%), headache (3.3%) and injection site reactions (2.8%, erythema, edema, pain, bruising, swelling). MOST SERIOUS: Serious infections (0.3%); evaluate for tuberculosis infection before starting bimekizumab therapy. Serious hypersensitivity reactions, potential for immunogenicity. Cases of new or exacerbations of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) were seen in clinical studies; not recommended in patients with inflammatory bowel disease. Read: Risk for myocarditis, pericarditis may depend on which mRNA vaccine is used DRUG INTERACTIONS Avoid live vaccines (inactivated or non-live vaccines can be safely administered). Potential to lower exposure of medications metabolized by CYP450, which could result in a clinically significant effect on CYP450 substrates with a narrow therapeutic index (e.g., warfarin); consider therapeutic monitoring when bimekizumab therapy is started. STORAGE Store in a refrigerator (2°C–8°C) in the original carton to protect from light. Do not freeze. May be stored at room temperature (up to 25°C), protected from light, for a maximum of 25 days. Do not put prefilled syringes or autoinjectors back in the refrigerator once they have reached room temperature. Evusheld for COVID-19 pre-exposure prophylaxis tixagevimab 100 mg/mL injection and cilgavimab 100 mg/mL injection (1.5 mL vials of each drug, co-packaged), AstraZeneca. INDICATIONS Pre-exposure prophylaxis of COVID-19 in adults and adolescents (≥12 years of age weighing at least 40 kg). Intended for those who have not had a known recent exposure to an individual infected with SARS-CoV-2 and are immunocompromised and unlikely to mount an adequate immune response to COVID-19 vaccination, or those for whom COVID-19 vaccination is not recommended (e.g., a history of anaphylaxis to a COVID-19 vaccine or its components). Pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Read: Physician and pharmacist team up to offer hair loss solutions ACTION Tixagevimab and cilgavimab are long-acting recombinant human IgG1 monoclonal antibodies that act as SARS-CoV-2 spike protein-directed attachment inhibitors. They bind to nonoverlapping regions of the spike protein receptor binding domain of SARS-CoV-2, blocking its interaction with the human ACE2 receptor. The estimated median terminal elimination half-life is 89 days for tixagevimab and 84 days for cilgavimab. DOSAGE Tixagevimab 150 mg and cilgavimab 150 mg, administered as two separate 1.5 mL sequential intramuscular injections at different sites, preferably one injection in each of the gluteal muscles. Consideration should be given to increasing the dose to tixagevimab 300 mg (2 vials, 3 mL) and cilgavimab 300 mg (2 vials, 3 mL) in regions where Omicron BA.1 and Omicron BA.1.1 subvariants are circulating, as the combination product has reduced neutralizing activity in vitro against these Omicron subvariants. Evusheld is currently approved to be given as a single dose only; safety and efficacy data are lacking on repeat dosing. ADVERSE EFFECTSMOST COMMON: Injection site reactions, including pain, erythema, pruritus, induration (1.3%). MOST SERIOUS: In clinical trials versus placebo, Evusheld had a higher incidence of serious cardiovascular events (0.7% versus 0.3%), particularly myocardial infarction and cardiac failure, and serious thromboembolic events (0.5% versus 0.2%). Most subjects had cardiac risk factors and/or a history of cardiovascular disease; a causal relationship has not been established. Consider the risks and benefits before using Evusheld in individuals at high risk for cardiovascular or thromboembolic events. Serious hypersensitivity reactions, including anaphylaxis, have been observed rarely with other IgG1 monoclonal antibodies. DRUG INTERACTIONS Not renally excreted or metabolized by CYP450 enzymes; therefore, unlikely to interact with concomitant medications that are renally excreted or that are substrates, inducers or inhibitors of CYP450 enzymes.. STORAGE Store in a refrigerator (2°C–8°C) in the original carton to protect from light. Do not freeze or shake. Read: Half-hour online training session helps teenagers deal with academic-related stress: study STABILITY Tixagevimab and cilgavimab solutions are preservative-free. Once drawn up into syringes, the injections should be administered immediately. If immediate administration is not possible, the prepared syringes can be stored for a total time of up to four hours (from vial puncture to administration) in a refrigerator (2ºC–8ºC) or at room temperature (up to 25ºC). COMMENTS First monoclonal antibody product to be approved for pre-exposure prophylaxis of COVID-19. First monoclonal antibody product for COVID-19 to be given by IM route of administration. Will initially be supplied in vials and cartons with English-only labelling. Vraylar, a new atypical antipsychotic cariprazine 1.5 mg, 3 mg, 4.5 mg and 6 mg capsules (as cariprazine hydrochloride), Allergan/AbbVie. INDICATIONS 1. Treatment of schizophrenia in adults. Improves both positive and negative symptoms. 2. Bipolar I disorder. Indicated as monotherapy for bipolar mania (acute management of manic or mixed episodes associated with bipolar I disorder) in adults and as monotherapy for bipolar depression (acute management of depressive episodes associated with bipolar I disorder) in adults. Not indicated in elderly patients with dementia-related psychosis. Read: Why test for lipoprotein-a when there’s not much doctors can do? ACTION Therapeutic effect may be mediated through a combination of partial agonist activity at central dopamine D3, D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Cariprazine’s two major metabolites (desmethyl cariprazine and didesmethyl cariprazine) have activity profiles similar to the parent drug. Terminal elimination halflife (total) for cariprazine and its two active metabolites is 8.9 ± 9.19 days. DOSAGE Due to the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks. Schizophrenia or bipolar mania: Start with 1.5 mg once daily, with or without food. If needed, increase gradually in 1.5 mg increments. Recommended target dosage is 1.5–6 mg once daily (maximum 6 mg daily). Bipolar depression: Start with 1.5 mg once daily, with or without food. Depending on clinical response and tolerability, the dose may be increased to a maximum of 3 mg once daily on day 15. No dosage adjustment is required in mild to moderate hepatic or mild to moderate renal impairment. Not recommended in severe hepatic or severe renal impairment. ADVERSE EFFECTSMOST COMMON: Extrapyramidal symptoms, akathisia dyspepsia, nausea, vomiting, somnolence and restlessness. Adverse events may first appear several weeks after starting therapy, since plasma levels of cariprazine and its major metabolites accumulate over time. MOST SERIOUS: Drug-related somnolence, postural hypotension, motor and sensory instability may lead to falls/ fractures. May cause metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia and weight gain; monitor blood glucose, lipids and weight at baseline and periodically thereafter. Can cause hypertension and tachycardia; monitor blood pressure before starting treatment and periodically throughout treatment. May cause orthostatic hypotension and syncope (symptoms include dizziness, light-headedness, tachycardia), particularly during initial dose titration and when increasing the dose. Potential to cause QT prolongation; use cautiously in patients with known cardiovascular disease, a family history of QT prolongation, or taking medications that might cause QT prolongation. Potential to cause neuroleptic malignant syndrome. Lens changes and cataracts have been seen during longterm therapy, but causal relationship not established; recommend an ophthalmologic exam if patients develop vision changes during treatment. Read: Exciting times for the treatment of the common molluscum contagiosum skin disease DRUG INTERACTIONS Extensively metabolized by CYP3A4 and, to a lesser extent, by CYP2D6. Concomitant use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, protease inhibitors) or moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin) is contraindicated during cariprazine treatment and for at least two weeks after cariprazine discontinuation. Caution with weak CYP3A4 inhibitors (e.g., ranitidine) or CYP3A4 substrates (e.g., midazolam, triazolam). Concomitant use of strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, efavirenz, bosentan, St. John’s wort) is contraindicated during cariprazine treatment. Uncertain whether cariprazine reduces the effectiveness of systemically acting hormonal contraceptives; female patients must use an alternate or concomitant method of contraception. COMMENTS Vraylar is new to Canada, but has been marketed in the United States since 2016.

New products: Latest drug releases for June/July

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