April 2024

New Products

• Fezolinetant (Veoza) is a nonhormonal selective NK₃ receptor antagonist that blocks neurokinin B (NKB) binding on kisspeptin/neurokinin B/dynorphin (KNDy) neurons to modulate neuronal activity in the thermoregulatory centre. The thermoregulatory centre in the hypothalamus is innervated by KNDy neurons, which are inhibited by estrogen and stimulated by the neuropeptide NKB. Through the menopausal transition, declining estrogen disrupts the balance with NKB. Unopposed, NKB signalling increases KNDy neuronal activity leading to hypertrophy of KNDy neurons and altered activity on the thermoregulatory centre, resulting in vasomotor symptoms (VMS), also known as hot flashes and night sweats. Veoza is indicated for the treatment of moderate to severe VMS associated with menopause. Veoza is contraindicated for concomitant use with moderate or strong CYP1A2 inhibitors; in patients with pre-existing Child‑Pugh Class B (moderate) or Class C (severe) chronic hepatic impairment; and in patients with severe or end-stage renal impairment (eGFR < 30 mL/min/1.73 m²). Veoza tablets contain fezolinetant 45 mg and are available in packs of 30.
   
• Prasterone (Intrarosa) is biochemically and biologically identical to endogenous human dehydroepiandrosterone, a precursor steroid with no or little pharmacological activity itself that is converted into estrogens and androgens. The metabolites formed from prasterone activate estrogen and androgen receptors. Intrarosa is thus different from estrogen preparations since it also delivers androgen metabolites. An increase in the number of superficial and intermediate cells and decrease in the number of parabasal cells in the vaginal mucosa is noted. In addition, the vaginal pH decreases towards the normal range, thus facilitating the growth of normal bacterial flora. Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms. Intrarosa is contraindicated in women with undiagnosed genital bleeding; known, past or suspected breast cancer; known or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer) or pregnancy; untreated endometrial hyperplasia; acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal; previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism); known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency); active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction); and porphyria. Intrarosa pessaries contain prasterone 6.5 mg and are available in packs of 28. 
   
• Recombinant respiratory syncytial virus pre-fusion F protein (RSVPreF3) vaccine (Arexvy) is derived from the laboratory-adapted respiratory syncytial virus (RSV)‑A, A2 strain, stabilised in the pre-fusion conformation of the naturally occurring F protein for which both RSV‑A and B subtypes share high amino acid sequence homology. It is adjuvanted with AS01_E, composed of the plant extract Quillaja saponaria saponin (QS‑21) and 3‑O‑desacyl‑4’-monophosphoryl lipid A (MPL) from Salmonella minnesota. Arexvy induces the functional humoral immune responses against the RSV‑A and RSV‑B subtypes and the antigen-specific cellular immune responses which contribute to protect against RSV-associated lower respiratory tract disease (LRTD). Non-clinical data show that AS01_E induces a local and transient activation of the innate immune system. The adjuvant effect of AS01_E is the result of interactions between MPL and QS‑21 formulated in liposomes. This facilitates the recruitment and activation of antigen presenting cells carrying vaccine-derived antigens in the draining lymph node, which in turn leads to the generation of RSVPreF3-specific CD4+ T cells and induction of RSV‑A and RSV‑B neutralising antibody responses. In addition, RSVPreF3 formulated with AS01_E can elicit specific binding antibodies directed to site Ø, a highly neutralising sensitive epitope, exposed only on the pre-fusion conformation of the F protein. Arexvy is indicated for active immunisation of individuals 60 years and older for the prevention of LRTD caused by RSV in accordance with official recommendations. Arexvy powder for injection contains RSVPreF3 120 micrograms per 0.5 mL and is available in packs of 1 or 10 vials of powder plus 1 or 10 vials of diluent.

New Presentation

• Melatonin (Voquily) is now available as capsules and as an oral solution. Voquily is indicated for short-term treatment of jet lag in adults aged 18 and over, and for sleep disorders in children and adolescents aged 6 to 18 with neurodevelopmental disorders including autism spectrum disorder and attention deficit hyperactivity disorder, where sleep hygiene measures have been insufficient. Voquily capsules contain melatonin 2, 3, or 5 mg and are available in packs of 30. Voquily oral solution contains melatonin 1 mg per 1 mL and is available in a 150 mL bottle.

New Indications

• Empagliflozin (Jardiance) is now indicated to reduce the risk of kidney disease progression in adults with chronic kidney disease (CKD) stages 2 and 3A with urine albumin to creatinine ratio (UACR) ≥ 30 mg/g, or CKD stages 3B, 4 and 5 irrespective of UACR.
   
• Pembrolizumab (rch) (Keytruda) is now indicated as monotherapy for the adjuvant treatment of patients with Stage IB (T2a ≥ 4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.

New Contraindications

• Morphine sulfate pentahydrate (DBL Morphine Sulfate Injection) is now contraindicated in respiratory failure; bronchial asthma or other obstructive airways disease (regardless of disease duration, severity); emphysema (any severity); severe depressed level of consciousness; diabetic ketoacidosis; and alcoholism or delirium tremens (regardless of disease duration).
   
• Nirmatrelvir and ritonavir (Paxlovid) is now contraindicated for concomitant use with sildenafil when used for pulmonary hypertension; avanafil and vardenafil when used for erectile dysfunction; and zolpidem.

Safety Related Changes

• Empagliflozin (Jardiance) is no longer contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73m²) in the treatment of type 2 diabetes.

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.