In line with NICE MTA 276 as an option for treating chronic pulmonary infection caused by P. aeruginosa in people with cystic fibrosis only if:

• nebulised tobramycin is considered an appropriate treatment, that is, when colistimethate sodium is contraindicated, is not tolerated or has not produced an adequate clinical response and
• the manufacturer provides tobramycin DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS.

300mg nebuliser solution

Management of chronic pulmonary infection due to Pseudomonas aeruginosa in people with cystic fibrosis aged 6 years and older.

 Second-line when colistimethate sodium is contraindicated, is not tolerated or has not produced an adequate clinical response.

Therapy should be initiated by a physician experienced in the management of cystic fibrosis.

 In line with NICE MTA 276 as an option for treating chronic pulmonary infection caused by P. aeruginosa in people with cystic fibrosis only if:

• they would clinically benefit from continued colistimethate sodium but do not tolerate it in its nebulised form and thus tobramycin therapy would otherwise be considered and

• the manufacturer provides colistimethate sodium DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS.

'Alert' antimicrobial - only on the advice of a GI specialist

 Second line antibiotic in adults who present with recurrent encephalopathy despite being on lactulose and neomycin.

Restricted for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis as a third line treatment option after colistimethate sodium (first line) and tobramycin (second line).

• Treatment should be under the supervision of a physician experienced in the treatment of lung infection in cystic fibrosis.

Restricted (off-label use) for the treatment of azithromycin resistant/macrolide resistant mycoplasma genitalium in adolescents and adults (16 years and older) in line with BASHH guidelines.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Consideration should be given to official guidance on the appropriate use of antifungal agents.

Restricted to use on the advice of a Medical Microbiologist, Infection specialist or Haematologist and inclusion in the NHS Grampian Staff Guidance for Optimising Use of Alert (Restricted) Antimicrobials in Adults, for the treatment of adults with:

• invasive aspergillosis
• mucormycosis in patients for whom amphotericin B is inappropriate

Isavuconazole 200mg powder for concentrate for solution (Cresemba®)

Isavuconazole 100mg hard capsules (Cresemba®)

 Risk Minimisation Materials

Risk Minimisation Materials

Risk Minimisation Materials

Descovy® 200/25 film-coated tablets
(200mg emtricitabine/25mg tenofovir alafenamide)
Descovy® 200/10 film-coated tablets
(200mg emtricitabine/10mg tenofovir alafenamide)

Kaletra® 200/50 film-coated tablets (200mg lopinavir/50mg ritonavir)
Kaletra® 400mg/100mg/5mL oral solution (80mg lopinavir/20mg ritonavir/mL)

To be used in the management of HIV for dialysis and severely impaired renal patients.

Letermovir should be initiated by a physician experienced in the management of patients who have had an allogeneic HSCT.

 To be supervised by the haematology department.

For prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT) as per SMC 1338/18.

 Valganciclovir should be initiated by physicians experienced in the care of post-transplant patients.

Prevention of cytomegalovirus (CMV) disease in CMV negative patients adults and children (aged from birth to 18 years) who have received a solid organ transplant from a CMV positive donor.

Duration of treatment: starting within 10 days post-transplantation and continuing until 100 days post-transplantation; for kidney transplant patients, prophylaxis may be continued until 200 days post-transplantation, see SmPC for more information.

 For adults with chronic hepatitis B infection when first-line treatments cannot be used

Risk Minimisation Materials

 Restricted to use in patients for whom a solid dosage form is not appropriate:

• adolescents 12 to < 18 years of age  with compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis
• adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis
• adults with decompensated liver disease

 Restricted to use in paediatric patients and those unable to swallow tablets.

Available in line with national guidance

Available in line with national guidance.

Available in line with national guidance

Available in line with national guidance

Available in line with national guidance

Available in line with national guidance

Antivirals for the treatment and prophylaxis of influenza should only to be used when predefined threshold is reached and announcement made by the Scottish Government

Antivirals for the treatment and prophylaxis of influenza should only to be used when predefined threshold is reached and announcement made by the Scottish Government

 For the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥ 6 months) when:

• the patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or
• other antiviral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient