The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Aripiprazole (Abilify®) has been accepted for restricted use in the treatment of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older for up to 12 weeks. The restriction recommends that treatment is initiated and supervised by a child/adolescent psychiatrist.
Lixisenatide (Lyxumia®) has been accepted for restricted use in the treatment of adults with type 2 diabetes mellitus in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. The restriction limits use to patients for whom a glucagon-like protein-1 (GLP-1) agonist is appropriate, as an alternative to existing GLP-1 agonists.
Medroxyprogesterone acetate (Sayana Press®) has been accepted for long-term female contraception. This review notes that return to fertility (ovulation) may be delayed for up to one year. It is also noted that treatment in individuals who are 12-18 years old should be limited to when other contraceptive methods are considered unsuitable or unacceptable due to unknown long-term effects of bone loss.
Rifaximin (Targaxan®) has been accepted to reduce the recurrence of episodes of overt hepatic encephalopathy (HE) in patients 18 years of age and older.
In addition, there are five reviews of medicines for the treatment of HIV-1 infection where use is restricted to a specialist:
- Tenofovir disoproxil granules (Viread®) in children aged 2 to 6 years of age, and above 6 years of age for whom a solid dosage
- Tenofovir disoproxil (Viread®) in paediatric and adolescent patients aged 6 to 12 years
- Tenofovir disoproxil (Viread®) in paediatric and adolescent patients aged 12 to 18 years
- Etravirine (Intelence®) in paediatric patients from 6 years to less than 18 years of age
- Raltegravir (Isentress®) in adolescents and children aged 2 to 17 years
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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