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Information Letter on Lynparza® 50 mg hard capsules (active ingredient olaparib): discontinuation of production at the end of 2021 PDF, 83KB, File is accessible Date: 29. June 2021 Topics: Pharmakovigilanz Aktuelles Type: Direct Healthcare Professional Communication

Active substance: olaparib

AstraZeneca informs that the production of Lynparza® 50 mg hard capsules (active ingredient: olaparib) will be discontinued at the end of 2021.

Direct Healthcare Professional Communication (DHPC) on Minprostin®, Prepidil®, Propess® (dinoprostone-containing drugs): updates to product information on risk reduction of uterine hyperstimulation, uterine rupture, and fetal/neonatal death. PDF, 295KB, File is accessible Date: 28. June 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dinoprostone

The product information for dinoprostone-containing drugs (Minprostin®, Prepidil®, Propess®) is updated.

Information Letter on INOmax® 800 ppm mol/mol, gas for medical use: difficulties with closing cylinder valves after use PDF, 127KB, File is accessible Date: 18. June 2021 Topics: Pharmakovigilanz Aktuelles Type: Direct Healthcare Professional Communication

Active substance: Nitric Oxide

The company Linde Healthcare AB informs that INOmax® cylinders that are not completely empty cannot be closed properly after opening.

Direct Healthcare Professional Communication (DHPC) on Amiodaron-hameln 50 mg/ml Concentrate for Solution for Injection/Infusion: visual inspection required due to possible crystallization PDF, 164KB, File is accessible Date: 17. June 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: amiodarone

The company Hameln Pharma GmbH would like to inform that there is an increased potential for crystallization in ampoules.

Direct Healthcare Professional Communication (DHPC) on Venclyxto® (venetoclax) film coated tablets: updated recommendations on tumour lysis syndrome (TLS) in CLL patients PDF, 110KB, File is accessible Date: 10. June 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: venetoclax

AbbVie in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you of fatal cases of TLS.

Direct Healthcare Professional Communication (DHPC) on Azazitidin 25 mg/ml: letter to healthcare professionals about potential risk of incorrect reconstitution (medication error) PDF, 257KB, File is accessible Date: 20. May 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: azacitidine

The marketing authorization holders of Azacitidin 25 mg/ml would like to inform in agreement with the Federal Institute for Drugs and Medical Devices (BfArM) of the new 150 mg azacitidine presentation on the market and the potential risk of …

Direct Healthcare Professional Communication (DHPC) on Eylea® 40 mg/ml (aflibercept solution for intravitreal injection): higher risk of intraocular pressure increase with the pre-filled syringe PDF, 468KB, File is accessible Date: 15. April 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aflibercept

Bayer, in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to inform of cases of increased intraocular pressure.

Direct Healthcare Professional Communication (DHPC) on ▼Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF— alpha inhibitors PDF, 322KB, File is accessible Date: 25. March 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Preliminary results from a clinical trial suggest an increased risk of serious cardiovascular events and malignancies (other than NMSC) with the use of tofacitinib compared to TNF-alpha inhibitors.

Direct Healthcare Professional Communication (DHPC) on Cabazitaxel Accord® 20 mg/ml concentrate for solution for infusion: risk of medication errors and confusion with Jevtana® (60 mg/1.5 ml) concentrate and solvent for solution for infusion PDF, 244KB, File is accessible Date: 09. March 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cabazitaxel

Accord Healthcare S.L.U., Spain, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), would like to inform about the risk for the occurrence of medication errors due …

Direct Healthcare Professional Communication (DHPC) on Lojuxta® (Lomitapide): liver function monitoring and contraindication during pregnancy PDF, 271KB, File is accessible Date: 17. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lomitapide

The company Amryt Pharmaceuticals DAC, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), reminds that lomitapide is contraindicated in patients with impaired liver …

Information Letter on Mitem 20 mg Powder for Solution for Injection or Infusion or Powder and Solvent for Solution for Intravesical Use: Design change of saline bags PDF, 423KB, File is accessible Date: 17. February 2021 Topics: Pharmakovigilanz Aktuelles Type: Direct Healthcare Professional Communication

Active substance: Mitomycin

The company Substipharm informs about a change in the design of sodium chloride bags.

Direct Healthcare Professional Communication (DHPC) on Miltefosin (Impavido® 10 mg/50 mg Capsules): new warning about ocular changes, including keratitis PDF, 638KB, File is accessible Date: 05. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs in coordination with the Federal Institute for Drugs and Medical Devices (BfArM) that in a few case reports complications of the eye (including keratitis) occurred under treatment with …

Direct Healthcare Professional Communication (DHPC) on Alkindi® (hydrocortisone granules in capsules for opening): risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations PDF, 798KB, File is accessible Date: 04. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydrocortisone

Diurnal Europe B.V. informs about the report of an adrenal crisis in an infant who was switched from soluble hydrocortisone tablets to Alkindi®.

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg: indications for uterine fibroids restricted due to concerns of severe liver injury PDF, 681KB, File is accessible Date: 01. February 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

The marketing authorization holders, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), inform about new restrictions for the use of ulipristal acetate 5 mg.

Direct Healthcare Professional Communication (DHPC) on metamizole: risk of drug-induced liver injury PDF, 212KB, File is accessible Date: 15. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that cases of …

Direct Healthcare Professional Communication (DHPC) Gliolan® (5-aminolevulinic acid, 5-ALA): what to do in case of delayed surgery and information on fluorescence in non high-grade glioma PDF, 470KB, File is accessible Date: 01. December 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-Aminolävulinsäure, 5-ALA

medac GmbH, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), provides information on the procedure for delayed operations and on fluorescence in non-high-grade gliomas.

Direct Healthcare Professional Communication (DHPC) on Gilenya® (fingolimod): updated recommendations to minimise the risk of drug-induced liver injury (DILI) PDF, 165KB, File is accessible Date: 10. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Novartis would like to inform you in agreement with European Medicines Agency (EMA) and Federal Institute for Drugs and Medical Devices, of cases of acute liver failure requiring liver transplant and clinically significant liver injury have …

Direct Healthcare Professional Communication (DHPC) on Tecfidera® (dimethyl fumarate): updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia PDF, 90KB, File is accessible Date: 09. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

Biogen Netherlands B.V. informs that cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients treated with Tecfidera with existing mild lymphopenia (lymphocyte value ≥ 0.8 x 109/l and below the lower standard …

Direct Healthcare Professional Communication (DHPC) on Esbriet®: important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI) Date: 29. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Pirfenidone

Roche Pharma Ltd informs about severe cases of drug-induced liver injury (DILI) recently reported using Esbriet® (Pirfenidone).

Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence PDF, 128KB, File is accessible Date: 29. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of fluoroquinolone antibiotics products would like to inform you about the risk of heart valve regurgitation/incompetence associated with fluoroquinolones for systemic and inhalation use.

Dear Doctor Letter (Rote-Hand-Brief) on Kybella® 10 mg/ml solution for injection (deoxycholic acid): risk of injection-site necrosis PDF, 270KB, File is accessible Date: 15. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: deoxycholic acid

The Marketing Authorisation Holder (MAH) informs about the risk of injection-site necrosis.

Direct Healthcare Professional Communication (DHPC) on leuprorelin-containing depot drugs: need to strictly follow the instructions regarding preparation and administration to reduce the risk of application errors PDF, 85KB, File is accessible Date: 30. July 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin

The marketing authorisation holders of depot medicines containing leuprorelin would like to inform about application errors which could possibly lead to a reduced efficacy.

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: pre-treatment testing to identify DPD-deficient patients PDF, 109KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-fluorouracil, capecitabine, tegafur

The marketing authorisation holders of medicines containing 5-fluorouracil i.v. (5-FU), capecitabine or tegafur, would like to inform you that patients with partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency are at an …

Direct Healthcare Professional Communication (DHPC) on flucytosine: updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency PDF, 97KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Flucytosine

Mylan (Meda Pharma GmbH & Co KG) would like to inform you that the treatment with flucytosine is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) deficiency due to the risk of life-threatening toxicity.

Direct Healthcare Professional Communication (DHPC) on tolperisone: a reminder of the negative risk-benefit balance if the use is outside the authorised indication PDF, 952KB, File is accessible Date: 02. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolperisone

The marketing authorisation holders of tolperisone containing drugs are once again informing, that since 2013 tolperisone is only authorised for the symptomatic treatment of spasticity after a stroke in adult patients.

Information Letter on Anticholium® (physostigmine salicylate): change in the approval PDF, 158KB, File is accessible Date: 14. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: physostigmine salicylate

Dr. Franz Köhler Chemie GmbH informs about the change in the approval of Anticholium®. The intramuscular application is no longer approved. Anticholium® is now sodium metabisulfite free.

Direct Healthcare Professional Communication (DHPC) on brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine PDF, 572KB, File is accessible Date: 12. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: brivudine

Marketing authorisation holders of medicines containing brivudine inform that deaths may occur as a result of interaction between brivudine and fluoropyrimidines.

Direct Healthcare Professional Communication (DHPC) on cyproterone acetate: restrictions in use due to the risk of meningioma PDF, 723KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Cyproteronacetat

The marketing authorisation holders of cyproterone containing medicines would like to inform about the occurrence of meningiomas in association with the use of cyproterone acetate.

Information Letter on Zomacton® (somatropin): change in the trade names of the injection equipment for administering the drugs PDF, 192KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

Ferring Arzneimittel GmbH informs that the needle-free injection device ZomaJet 2 Vision for the administration of Zomacton® 4 mg has been renamed ZomaJet 4 and the needle-free injection device ZomaJet Vision X for the administration of …

Direct Healthcare Professional Communication (DHPC) on Trisenox® (arsenic trioxide): risk of medication errors due to the introduction of a 2 mg/ml vial replacing the 1 mg/ml glass vial PDF, 239KB, File is accessible Date: 31. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenic trioxide

The company Teva B.B. informs in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that the Trisenox® (arsenic trioxide) 1 mg/ml 10 ml ampoule (contains 10 mg arsenic …