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New Products
- Andexanet alfa (Andexxa) is a recombinant form of human factor Xa (FXa) protein that has been modified to lack FXa enzymatic activity. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma‑carboxyglutamic acid domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti‑coagulant effects. It is a specific reversal agent for FXa inhibitors. The predominant mechanism of action is the binding and sequestration of the FXa inhibitor. In addition, andexanet alfa has been observed to bind to, and inhibit tissue factor pathway inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor‑initiated thrombin generation inducing a pro‑coagulant effect. Andexxa has provisional approval for adult patients treated with a direct FXa inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life‑threatening or uncontrolled bleeding. Andexxa powder for solution for injection contains andexanet alfa 200 mg per vial and is available in packs of 4.
- Andusomeran (Spikevax XBB.1.5) is formulated in lipid particles, which enable delivery of the nucleoside‑modified mRNA into host cells to allow expression of the SARS‑CoV‑2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID‑19. Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID‑19 in individuals 12 years of age and older in accordance with official recommendations. Spikevax XBB 1.5 is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to a previous dose of Spikevax (original), Spikevax Bivalent Original/Omicron (BA.1), Spikevax Bivalent Original/Omicron BA.4‑5. Spikevax XBB.1.5 suspension for injection contains andusomeran 50 mcg per 0.5 mL dose and is available in packs of 10 single‑dose vials or prefilled syringes.
- Mavacamten (Camzyos) is a selective, allosteric, and reversible cardiac myosin inhibitor. Mavacamten modulates the number of myosin heads that can enter power‑generating states, thus reducing, (or in hypertrophic cardiomyopathy (HCM) normalizing), the probability of force‑producing systolic and residual diastolic crossbridge formation. Mavacamten also shifts the overall myosin population towards an energy sparing, but recruitable, super‑relaxed state. Excess cross‑bridge formation and dysregulation of the super‑relaxed state of myosin are mechanistic hallmarks of HCM, which can result in hypercontractility, impaired relaxation, excess energy consumption, and myocardial wall stress. In HCM patients, myosin inhibition with mavacamten normalizes contractility, reduces dynamic LV outflow tract obstruction, and improves cardiac filling pressures and biomarkers of cardiac stress, improving symptoms and exercise capacity. Camzyos is indicated for the treatment of adults with symptomatic NYHA class II‑III obstructive HCM. Camzyos is contraindicated in concomitant use with moderate to strong CYP2C19 inhibitors and inducers, strong CYP3A4 inhibitors, and moderate to strong CYP3A4 inducers. Camyzos capsules contain mavacamten 2.5 mg or 5 mg and are available in packs of 28.
- Rimegepant (Nurtec ODT) binds with high affinity to the human calcitonin gene‑related peptide (CGRP) receptor and antagonises CGRP receptor function. Multiple lines of clinical evidence point to a role for CGRP in migraine pathophysiology: 1) serum levels of CGRP are elevated during migraine; 2) treatment with anti‑migraine drugs returns CGRP levels to normal coincident with pain relief and 3) intravenous CGRP infusion produces lasting pain in non‑migraineurs and migraineurs. Nurtec ODT is indicated for acute treatment of migraine with or without aura in adults and as prophylactic treatment of episodic migraine in adults who have at least 4 migraine attacks per month. Nurtec ODT orally disintegrating tablets contain rimegepant 75 mg and are available in packs of 2, 4, 8 or 16.
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New Presentation
- Progesterone (Prolutex) is now available as a solution for injection. It is indicated in adults for luteal support as part of an Assisted Reproductive Technology treatment program in women who are unable to use or tolerate vaginal preparations, or where there is a need or preference to use an injectable form of progesterone. Prolutex is contraindicated in undiagnosed vaginal bleeding; known missed abortion or ectopic pregnancy; severe hepatic dysfunction or disease; known or suspected breast or genital tract cancer; active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events; porphyria; and in individuals with a history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy. Prolutex contains progesterone 25 mg per 1.112 mL vial and is available in packs of 7.
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New Indications
- Ivosidenib (Tibsovo) is now indicated for the treatment of acute myeloid leukaemia (AML) that carries an IDH1 R132 mutation as monotherapy, or in combination with azacitidine, in newly diagnosed patients who are not eligible to receive intensive induction chemotherapy; or as monotherapy in patients whose AML is relapsed and/or refractory to prior therapy.
- Secukinumab (Cosentyx) is now indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.
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New Contraindications
- Midodrine HCl (Vasodrine) is now contraindicated in obliterative blood vessel disease of any severity, acute nephritis, hypertrophy of the prostate gland with residual urine volume increased, and vasovagal hypotension.
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This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.
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