Adakveo Sterile Concentrate Solution for infusion

Crizanlizumab

10mg/ml

NOVARTIS PHARMACEUTICALS CORPORATION

Pack size	1 Glass Vial (10 ml)
Dispensing mode	POM
Source	USA
Agent	CITY MEDICAL STORE
Retail Price	8918.00 AED

Indications

Adakveo Sterile Concentrate Solution for infusion is used for: Sickle Cell Disease

Adult Dose

Sickle Cell Disease Indicated to reduce the frequency of vasoocclusive crises in adults with sickle cell disease 5 mg/kg IV on Week 0, Week 2, and q4Weeks thereafter

Child Dose

Sickle Cell Disease Indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged ?16 years with sickle cell disease <16 years: Safety and efficacy not established >16 years 5 mg/kg IV on Week 0, Week 2, and q4Weeks thereafter

Renal Dose

Renal impairment: Effect of renal or hepatic impairment on the pharmacokinetics of crizanlizumab-tmca is unknown

Administration

IV Preparation Bring vials to room temperature Visually inspect the vials and parenteral drug products for particulate matter and discoloration prior to administration Crizanlizumab is clear to opalescent, colorless, or may have a slightly brownish-yellow tint; do not use if particles are present in the solution Obtain a 100-mL 0.9% NaCl or dextrose 5% infusion bag/container Infusion bags/containers must be made of either polyvinyl chloride (PVC), polyethylene (PE), or polypropylene (PP) Remove a volume from the infusion bag/container that is equal to the required drug Withdraw required drug solution and dilute by adding to the infusion bag/container Drug volume added to the infusion bag/container should not exceed 96 mL Gently invert the infusion bag to mix the diluted solution; do not shake Discard any unused portion Dilute drug in 0.9% NaCl or dextrose 5% to a total volume of 100 mL IV Administration Infuse IV over 30 minutes through a line that must contain a sterile, nonpyrogenic 0.2-micron inline filter No incompatibilities have been observed with infusion sets composed of PVC, polyethylene (PE-lined PVC), polyurethane (PU), and inline filter membranes composed of polyethersulfone (PES, neutral and positively charged), positively charged polyamide (PA), and polysulphone (PSU) After administration, flush line with at least 25 mL of 0.9% NaCl or dextrose 5% Dispose of any unused product or waste material in accordance with local requirements May be given with or without hydroxyurea

Contra Indications

Precautions

In a clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed; monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, shortness of breath, or wheezing; discontinue infusion for severe reactions and institute appropriate medical care

Pregnancy-Lactation

Pregnancy Based on data from animal studies, fetal harm may occur when administered to a pregnant woman There are insufficient human data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Advise pregnant women of the potential risk to a fetus Only use during pregnancy if expected benefit justifies the potential risk to the fetus Animal data In an animal reproduction study, IV administration of crizanlizumab-tmca to pregnant cynomolgus monkeys from onset of organogenesis through delivery resulted in a non-dose-related increased fetal loss (abortions/stillbirths) at doses ~2.8 times the exposure at the recommended clinical dose at 5 mg/kg/dose once q4Weeks Disease-associated maternal and/or embryofetal risk Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus Pregnant women are at greater risk for vasoocclusive crises, preeclampsia, eclampsia, and maternal mortality For the fetus, there is an increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality Lactation There are no data on the presence of crizanlizumab-tmca in human or animal milk, the effects on the breastfed child, or the effects on milk production Maternal IgG is known to be present in human milk Effects of local gastrointestinal exposure and

Interactions

Interference with automated platelet counts (platelet clumping) has been observed following administration, in particular when blood samples were collected in tubes containing ethylenediaminetetraacetic acid (EDTA); mitigation strategies are recommended

Adverse Effects

Side effects of Crizanlizumab : >10% Nausea (18%) Arthralgia (18%) Back pain (15%) Pyrexia (11%) <10% Oropharyngeal pain Abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness) Diarrhea Vomiting Pruritus (pruritus and vulvovaginal pruritus) Musculoskeletal chest pain Myalgia Infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling) Infusion-related reaction

Mechanism of Action

A humanized IgG2 kappa monoclonal antibody binds to P-selectin and blocks interactions with its ligands, including P-selectin glycoprotein ligand 1 Binding P-selectin on the surface of the activated endothelium and platelets blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes

Note

Adakveo 10mg/ml Sterile Concentrate Solution for infusion manufactured by NOVARTIS PHARMACEUTICALS CORPORATION. Its generic name is Crizanlizumab. Adakveo is availble in United Arab Emirates. Farmaco UAE drug index information on Adakveo Sterile Concentrate Solution for infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.