Crizanlizumab (Adakveo)

Trade Name : ADAKVEO

Novartis Pharmaceuticals Corporation

INJECTION

Strength 10 mg/mL

CRIZANLIZUMAB

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Crizanlizumab (Adakveo) which is also known as ADAKVEO and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 10 mg/mL per ml. Read more

Crizanlizumab (Adakveo) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ADAKVEO is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.
  • ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.
  • Administer 5 mg/kg by intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter. ()
  • See Full Prescribing Information for instructions on preparation and administration. ()
  • Injection: 100 mg/10 mL (10 mg/mL) as a clear to opalescent, colorless to slightly brownish-yellow solution in a single-dose vial.
  • Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.
  • None.
  • None.
  • No data
  • Infusion-Related Reactions: Monitor patients for signs and symptoms. Discontinue ADAKVEO infusion for severe reactions and manage medically. ()nttttttttt
  • Interference With Automated Platelet Counts (platelet clumping): Run test as soon as possible or use citrate tubes. ()nttttttttt
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions (incidence > 10%) are nausea, arthralgia, back pain, and pyrexia. ()
  • Platelet Tests
  • ADAKVEO interferes with automated platelet counts (platelet clumping) in particular when blood samples are collected in tubes containing EDTA, which may lead to unevaluable or falsely decreased platelet counts. Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.
  • Pregnancy: May cause fetal harm. ()
  • Crizanlizumab-tmca is a selectin blocker humanized IgG2 kappa monoclonal antibody that binds to P-selectin. Crizanlizumab-tmca is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It is composed of 2 heavy chains, each containing 448 amino acids, and 2 light chains each containing 218 amino acids, with a theoretical molecular weight of approximately 146 kDa.
  • ADAKVEO (crizanlizumab-tmca) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to slightly brownish-yellow solution for dilution and subsequent administration by intravenous infusion. Each 10 mL vial contains 100 mg crizanlizumab-tmca, citric acid (5.4 mg), polysorbate 80 (2 mg), sodium citrate (50.5 mg), sucrose (753.3 mg) and water for injection with a pH of 6.
  • No data
  • No data
  • The efficacy of ADAKVEO was evaluated in patients with sickle cell disease in SUSTAIN [NCT01895361], a 52-week, randomized, multicenter, placebo-controlled, double-blind study. A total of 198 patients with sickle cell disease, any genotype (HbSS, HbSC, HbS/beta-thalassemia, HbS/beta-thalassemia, and others), and a history of 2-10 VOCs in the previous 12 months were eligible for inclusion. Patients were randomized 1:1:1 to ADAKVEO 5 mg/kg (N = 67), ADAKVEO 2.5 mg/kg (N = 66), or placebo (N = 65) administered over a period of 30 minutes by intravenous infusion on Week 0, Week 2, and every 4 weeks thereafter for a treatment duration of 52 weeks. Randomization was stratified by patients already receiving hydroxyurea (Y/N) and by the number of VOCs in the previous 12 months (2 to 4, 5 to 10).
  • Patients received ADAKVEO (with or without hydroxyurea) and were allowed to receive occasional transfusions and pain medications [i.e., acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and opioids] on an as needed basis.
  • Patients recruited in the study had complications associated with sickle cell disease and other comorbidities including a history of acute chest syndrome (18%); pulmonary hypertension (8%); priapism (7%); psychiatric manifestations (25%) including depression and anxiety; hypertension (17%); cholelithiasis (17%). Demographic and other baseline characteristics were similar among the treatment groups (see Table 2).
  • Efficacy was evaluated in the SUSTAIN study by the annual rate of VOCs leading to a healthcare visit. A VOC leading to a healthcare visit was defined as an acute episode of pain with no cause other than a vaso-occlusive event that required a medical facility visit and treatment with oral or parenteral opioids, or parenteral NSAIDs. Acute chest syndrome, hepatic sequestration, splenic sequestration, and priapism (requiring a visit to a medical facility) were also considered VOCs.
  • Patients with sickle cell disease who received ADAKVEO 5 mg/kg had a lower median annual rate of VOC compared to patients who received placebo (1.63 vs. 2.98) which was statistically significant (p = 0.010). Reductions in the frequency of VOCs were observed among patients regardless of sickle cell disease genotype and/or hydroxyurea use.
  • Thirty-six percent (36%) of patients treated with ADAKVEO 5 mg/kg did not experience a VOC compared to 17% of placebo-treated patients. The median time to first VOC from randomization was 4.1 months in the ADAKVEO 5mg/kg arm compared to 1.4 months in the placebo.
  • The main efficacy results of the pivotal study, SUSTAIN, are summarized in Table 3.
  • How Supplied
  • ADAKVEO (crizanlizumab-tmca) injection is a sterile, clear to opalescent, colorless to slightly brownish-yellow solution for intravenous infusion supplied as:
  • Carton containing one 100 mg/10 mL (10 mg/mL) single-dose vialu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0078-0883-61
  • The single-dose vial has a rubber stopper and an aluminum cap with a plastic flip-off disk. Each 10 mL vial is made of Type 1 glass.
  • Storage and Handling
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Infusion-Related Reactions
  • Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions .
  • Interference With Automated Platelet Counts
  • Advise patients to inform their healthcare provider that they are receiving ADAKVEO prior to any blood tests due to the potential interference with laboratory tests used to measure platelet counts .
  • Manufactured by:Novartis Pharmaceuticals CorporationOne Health PlazaEast Hanover, New Jersey 07936
  • US License No. 1244
  • u00a9 Novartis
  • T2019-119
  • No data
  • NDC 0078-0883-61
  • Rx Only
  • ADAKVEOn
  • (crizanlizumab-tmca)Injection
  • 100 mg/10 mL(10 mg/mL)
  • For intravenous infusion after dilution.
  • 1 Single-Dose Vial.Discard Unused Portion.
  • NOVARTIS

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