First azacitidine approvals here

Hamburg / Dassow, February 1st, 2021

At the end of January, the first azacitidine approvals were received for two European countries: Malta and Iceland.

AqVida is thus expanding its product portfolio to include azacitidine AqVida 25 mg / ml powder for the preparation of a suspension for injection to combat acute myeloid leukemia (AML).

A generic product with added value: AqVida also offers azacitidine in the 150 mg pack size in addition to the standard market pack size of 100 mg. Because in around 90% * of all patients, the contents of a vial are sufficient to prepare a suspension for injection.

For pharmacies, this means more economical work and significantly less waste.



* Evaluation based on the average body surface area of a Central European (Journal of Clinical Oncology. 21 (14): 2803–4. Doi: 10.1200 / JCO.2003.99.038. PMID 12860961)

Azacitidine AqVida 25 mg / ml powder for suspension for injection. Active ingredient: azacitidine. Otherwise. Components: Mannitol (Ph.Eur.), Applic .: For treatment. v. exp. Patients who are not suitable for HSCT and one of the following The following clinical pictures show: MDS with intermediate risk 2 or high risk according to IPSS, CMML with 10–29% bone marrow blasts without myeloproliferative disorders, AML with 20–30% blasts and multiline dysplasia according to WHO, AML with <30% bone marrow blasts according to WHO, Gegenanz .: Hypersensitivity to the active ingredient or mannitol, advanced. Malignant liver tumors, lactation, incidental conditions: Very common: Pneumonia, nasopharyngitis, (febrile) neutropenia, leukopenia, thrombocytopenia, anemia, anorexia, loss of appetite, hypokalaemia, insomnia, dizziness, headache, dyspnoea, epistaxis, diarrhea, vomiting, constipation, nausea, abdominal pain, petechiae, pruritus, rash, ecchymosis, arthralgia, musculoskeletal pain, pyrexia, fatigue, asthenia, chest pain, erythema / pain / reaction to d. Injection site, weight loss. Common: (neutropenic) sepsis, infection d. Respiratory tract, urinary tract infection, cellulitis, diverticulitis, oral fungal infection, sinusitis, pharyngitis, rhinitis, herpes simplex, skin infection, pancytopenia, bone marrow failure, dehydration, confusion, anxiety, intracranial hemorrhage, syncope, somnolence, lethargy, conjunctival hemorrhage, eye bleeding , (orthostatic) hypotension, hematoma, pleural effusion, exertional dyspnea, pharyngolaryngeal pain, gastrointest. Bleeding, hemorrhoidal bleeding, stomatitis, bleeding gums, dyspepsia, purpura, alopecia, urticaria, erythema, macular rash, muscle spasms, myalgia, kidney failure, hematuria, increased serum creatinine, bruising, hematoma, hardening, discoloration, inflammation, pruritis, etc. Bleeding, malaise, chills, bleeding from d. Catheter puncture site. Uncommon: hypersensitivity reaction, pericarditis, liver failure, progressive hepatic coma, acute febrile neutrophilic dermatosis, pyoderma gangrenosum, renal tubular acidosis. Rare: tumor lysis syndrome, interstitial lung disease, necrosis of the d. Injection site. Not known: necrotizing fasciitis. Warning: cytostatic agent. Store drug out of reach of children. Prescription only. Status: December 2020. AqVida GmbH, Kaiser-Wilhelm-Str. 89, 20355 Hamburg.

We are available for current company topics and interview requests:

Saskia Heinze

Claudia Schubert

Phone:  49 (0) 40/380 371 9 - 0

Mail: pr@aqvida.com