28/04/22 - Acalabrutinib hard capsules 100mg; cabozantinib film-coated tablets 20mg, 40mg, 60mg; olaparib tablets film-coated 100mg, 150mg; osimertinib film-coated tablets 40mg, 80mg; sacituzumab govitecan powder for concentrate for solution for infusion 180mg; trastuzumab deruxtecan powder for concentrate for solution for infusion 100mg; tucatinib tablets 50mg, 150mg; and venetoclax film-coated tablets 10mg, 50mg, 100mg added.
MHRA advice: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases (June 2021) (www.gov.uk).
Tablets 50mg, 100mg, 150mg
See SMC advice 2179.
Tablets 500mg (specialist use only)
1000mg once daily continued until disease progression or unacceptible toxicity
See SMC advice 2215.
Hard capsules 100mg (hospital use only)
See SMC advice 2346, 2347 and 2348.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot
Tablets 20mg, 30mg, 40mg, 50mg (specialist use only)
See SMC advice 920/13.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Concentrate for solution for infusion 25mg/mL (specialist use only)
See SMC advice 878/13.
Capsules 150mg (specialist use only)
See SMC advice 2012.
Injection 50mg/mL unlicensed
Concentrate for solution for infusion 1mg/ml (specialist use only)
See SMC advice 2181.
Tablets film-coated 20mg, 40mg (hospital use only)
See SMC advice 2482.
MHRA advice: Atezolizumab (Tecentriq) and other immune-stimulatory anti-cancer drugs: risk of severe cutaneous adverse reactions (SCARs) (June 2021) (www.gov.uk).
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Powder for suspension for injection 100mg
See SMC advice 589/09.
Also for selected patients with indolent (FCC, MCL, MZL, SLL, LPC) non-Hodgkin’s lymphoma.
MHRA advice: Bendamustine (Levact): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML) (March 2021) (www.gov.uk).
MHRA advice: Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation (July 2017) (www.gov.uk).
Powder for concentrate for solution for infusion 25mg, 100mg (specialist use only)
See SMC advice 694/11.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
MHRA advice: Bevacizumab and sunitinib: risk of osteonecrosis of the jaw (December 2014) (www.gov.uk).
MHRA advice: Bevacizumab (Avastin): hypersensitivity and infusion reactions (December 2014) (www.gov.uk).
Powder for solution for injection 15,000 units (specialist use only)
Tablets 100mg, 500mg (specialist use only)
See SMC advice 910/13.
Tablets 2mg (specialist use only)
MHRA advice: Cabazitaxel (Jevetana): risk of medication error resulting in overdose (December 2014) (www.gov.uk).
Concentrate for solution for infusion 40mg/mL (specialist use only)
See SMC advice 735/11.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Tablets 15mg (specialist use only)
MHRA advice: 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity (October 2020) (www.gov.uk).
Powder and solvent for solution for injection 10mg (specialist use only)
See SMC advice 2266.
Concentrate for solution for infusion 10mg/mL (specialist use only)
See NICE guidance CG121.
MHRA advice: Carfilzomib (Kyprolis): risk of reactivation of hepatitis B virus (November 2019) (www.gov.uk).
MHRA advice: Carfilzomib (Kyprolis): reminder of risk of potentially fatal cardiac events (August 2019) (www.gov.uk).
Capsules 150mg (specialist use only)
See SMC advice 1097/15.
Tablets 2mg (specialist use only)
Concentrate for solution for infusion 1mg/mL (specialist use only)
See NICE guidance NG122.
MHRA advice: Cladribine (Mavenclad): new advice to minimise risk of serious liver injury (March 2022) (www.gov.uk).
Risk minimisation materials
Solution for subcutaneous injection 2mg/mL (specialist use only)
See SMC advice 537/09.
Crisantaspase is the enzyme asparaginase produced by Erwinia chrysanthemi.
Powder for solution for injection 10,000 units (specialist use only)
MHRA advice: Cirzotinib (Xalkori): risk of cardiac failure (November 2015) (www.gov.uk).
Risk minimisation materials
Tablets 50mg (specialist use only)
Powder for solution for injection 1 gram (specialist use only)
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors (July 2020) (www.gov.uk).
Intrathecal injection 20mg/mL (specialist use only)
Injection 100mg/mL (specialist use only)
Capsules 50mg, 75mg (specialist use only)
See SMC advice 1023/15.
Injection 200mg, 500mg (specialist use only)
Tablets 15mg, 30mg and 45mg (specialist use only)
45mg once daily until disease progression or toxicity.
See SMC advice 2184.
Powder for solution for injection 500 micrograms (specialist use only)
MHRA advice: Daratumumab (Darzalex): risk of reactivation of hepatitis B virus (August 2019) (www.gov.uk).
Risk minimisation materials
Concentrate for solution for infusion 20mg/mL (specialist use only)
Solution for injection 120mg/mL (15mL) (hospital use only)
See SMC advice 2447.
Tablets 300mg (specialist use only)
See SMC advice 2297.
Tablets 20mg, 50mg, 80mg, 100mg, 140mg (specialist use only)
See SMC advice 370/07.
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors (July 2020) (www.gov.uk).
Powder for solution for infusion 20mg (specialist use only)
Injection 50mg/mL (specialist use only)
Concentrate for solution for infusion 500mg (hospital use only)
See SMC advice 2404.
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors. (July 2020) (www.gov.uk).
Solution for injection 2mg/mL (specialist use only)
Solution for infusion 2mg/mL (specialist use only)
Solution for injection 0·44mg/mL (specialist use only)
See SMC advice 1065/15.
Tablets 100mg, 150mg (specialist use only)
See SMC advice 220/05.
Capsules 100mg (hospital use only)
See SMC advice 2462.
Tablets 10mg (specialist use only)
MHRA advice: 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity (October 2020) (www.gov.uk).
Solution for infusion 25mg/mL, 50mg/mL (specialist use only)
Cream 5% (specialist use only)
Tablets, film coated 100mg, 150mg (hospital use only)
As per SMC advice 2300.
Solution for injection 250mg (specialist recommendation or initiation only)
For use as monotherapy see SMC advice 114/04.
For use with palbociclib (SMC advice 2149) see fulvestrant shared care protocol.
Powder for concentrate for solution for infusion 5mg (specialist use only)
See SMC advice 2089.
Tablets film-coated 40mg (hospital use only)
See SMC advice 2252.
Capsules 500mg (specialist use only)
Oral solution 100mg/mL (hospital use only)
See SMC advice 2271.
MHRA advice: Ibrutinib (Imbruvica) reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and or opportunistic infections (August 2017) (www.gov.uk).
Capsules 140mg (specialist use only)
Homecare is the preferred option - contact nhsh.homecare@nhs.scot
See SMC advice 1150/16, 1151/16.
Capsules 5mg, 10mg (specialist use only)
Powder for solution for injection 10mg (specialist use only)
MHRA advice: Idelalisib (Zydelig): updated indications and advice on minimising the risk of infection (September 2016) (www.gov.uk).
Powder for concentrate for solution for injection 1 gram, 2 grams (specialist use only)
For use in adult patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ALL).
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors (July 2020) (www.gov.uk).
Concentrate for solution for infusion 20mg/mL (specialist use only)
See NICE guidance CG131.
Concentrate for solution for infusion 20mg/ml (specialist use only)
See SMC advice 2303.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Powder for concentrate for solution for infusion 44mg/100mg (specialist use only)
See SMC advice 2130.
Capsules 40mg (specialist use only)
Tablets 2mg (specialist use only)
Tablets 50mg (specialist use only)
Oral suspension 100mg/mL (specialist use only)
See SMC advice 798/12.
Tablets 400mg (specialist use only)
Solution for injection 100mg/mL (specialist use only)
MHRA advice: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing (September 2020) (www.gov.uk).
Risk minimisation materials
Oral solution 10mg/5mL specialist use only)
Solution for injection 25mg/mL, 100mg/mL (specialist use only)
Intrathecal injection 50mg/2mL (specialist use only)
Tablets 50mg (specialist use only)
See SMC advice 1330/18.
Mitomycin 40mg is given as a bladder instillation.
Powder for solution for injection 10mg, 20mg, 40mg (specialist use only)
Concentrate for solution for infusion 2mg/mL (specialist use only)
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Capsules (Vargetef®) 100mg, 150mg (specialist use only)
See SMC advice 1027/15.
MHRA advice: Niraparib (Zejula): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment (October 2020) (www.gov.uk).
Concentrate for solution for infusion 25mg/mL
See SMC advice 1008/14.
Capsules 50mg (specialist use only)
See SMC advice 1047/15.
MHRA advice: Paclitaxel formulations (conventional and nab-paclitaxel): caution required due to potential for medication error (January 2022) (www.gov.uk).
MHRA advice: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases (June 2021) (www.gov.uk).
Concentrate for intravenous infusion 20mg/mL (specialist use only)
See NICE MTA 439.
Capsules 10mg, 15mg, 20mg (specialist use only)
See SMC advice 1122/16.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Tablets 200mg, 400mg (specialist use only)
See SMC advice 676/11.
Tablets 4.5mg, 9mg, and 13.5mg (hospital use only)
See SMC advice 2399.
Powder for solution for injection 10mg (specialist use only)
Solution for injection (Phesgo) 600mg/600mg, 1200mg/600mg (specialist use only)
See SMC advice 2364.
Powder for concentrate for solution for infusion 140mg (hospital use only)
See SMC advice 2282.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
MHRA advice: Ponatinib (Iclusig): reports of posterior reversible encephalopathy syndrome (October 2018) (www.gov.uk).
MHRA advice: Ponatinib (Iclusig): risk of vascular occlusive events - updated advice on possible dose reduction (April 2017) (www.gov.uk).
Tablets 15mg, 45mg (specialist use only)
See SMC advice 1032/15.
Capsules 50mg (specialist use only)
MHRA advice: Radium-223 dichloride (Xofigo): new restrictions on use due to increased risk of fracture and trend for increased mortality seen in clinical trial (September 2018) (www.gov.uk).
Solution for injection 1,000kBq/mL (specialist use only)
See SMC advice 1077/15.
Powder for solution for infusion 2mg (specialist use only)
See NICE guidance CG131.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Tablets 40mg (specialist use only)
See SMC advice 1031/15.
MHRA advice: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases (June 2021) (www.gov.uk).
Tablets 200mg (specialist use only)
600mg once daily for 3 weeks, repeat every 28 days
See SMC advice 1295/18.
Tablets 200mg, 250mg, 300mg (specialist use only)
See SMC advice 2224.
Powder for concentrate for solution for infusion 180mg (hospital use only)
See SMC advice 2446.
Capsules 40mg and 80mg (hospital use only)
See SMC advice 2370.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Tablets 200mg (specialist use only)
See SMC advice 482/08.
Film-coated tablets 120mg (hospital use only)
See SMC advice 2443.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
MHRA advice: 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity (October 2020) (www.gov.uk).
Capsules (Teysuno®) 15mg/4·35mg/11·8mg, 20mg/5·8mg/15·8mg (specialist use only)
See SMC advice 802/12.
MHRA advice: Temozolomide: risk of hepatic injury, including fatal hepatic failure - updated warnings and monitoring guidance (December 2014) (www.gov.uk).
Powder for concentrate for solution for infusion 1mg (specialist use only)
See NICE guidance TA389.
Powder for concentrate for solution for infusion 0·25mg, 1mg (specialist use only)
See SMC advice 2283.
MHRA advice: Trametinib (Mekinist): risk of gastrointestinal perforation and colitis (March 2016) (www.gov.uk).
Powder for concentrate for solution for infusion 100mg (hospital use only)
See SMC advice 2388.
Capsules 10mg (specialist use only)
Tablets 50mg, 150mg (hospital use only)
See SMC advice 2398.
MHRA advice: Vemurafenib (Zelboraf(: risk of potentiation of radiation toxicity (November 2015) (www.gov.uk).
Tablets 240mg (specialist use only)
See SMC advice 792/12.
Solution for injection 10mg (specialist use only)
Solution for injection 1mg/ml (specialist use only)
Powder for solution for injection 5mg (specialist use only)
Capsules 20mg, 30mg (specialist use only)
Concentrate for solution for infusion 10mg/mL (specialist use only)
See NICE guidance CG81.
Capsules 80mg (hospital use only)
See SMC advice 2528.
