To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
BLINCYTO (BLINATUMOMAB) The Warnings and Precautions section of the Package Insert (PI) was updated detailing Benzyl Alcohol Toxicity in Neonates. Serious adverse reactions, including fatal reactions and “gasping syndrome,” have been reported in very low birth weight (VLBW) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) who received intravenous drugs containing benzyl alcohol as a preservative. Early preterm VLBW neonates may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Additional guidance was included for preparing and prescribing the medication for this population including the recommendation to use the preservative-free formulations where possible in neonates. Information was included detailing Embryo-Fetal Toxicity and that BLINCYTO may cause fetal harm when administered to a pregnant woman. Clinical trial data was updated as well as the previously stated information in the section covering pediatric use. In the Patient Counseling Information, Tumor Lysis Syndrome (TLS) was added stating TLS is caused by the fast breakdown of cancer cells. TLS can be life-threatening and may lead to death. Patients are instructed to tell their healthcare provider right away if they have any symptoms of TLS during treatment with BLINCYTO, including nausea and vomiting, dark or cloudy urine, confusion, reduced amount of urine, shortness of breath, unusual tiredness, irregular heartbeat, and muscle cramps.
SMOFLIPID (FISH OIL/SOYBEAN OIL TRIGLYCERIDES) The Warnings and Precautions section of the PI was updated detailing clinical decompensation with rapid infusion in neonates and infants. Serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion. Hypertriglyceridemia was also commonly reported. Guidance was provided to strictly adhere to recommended total daily dosage; and that the hourly infusion rate should not exceed 0.75 mL/kg/hour.
INJECTAFER (FERRIC CARBOXYMALTOSE) The Warnings and Precautions section of the PI was updated to include reports of Symptomatic Hypophosphatemia. The Patient Counseling information was updated advising patients to report any signs or symptoms of hypophosphatemia such as fatigue, muscle weakness or pain, bone and joint pain, or bone fractures. This material instructs patients to report medical conditions to their healthcare provider before receiving INJECTAFER including a history of trouble absorbing certain vitamins or phosphate, inflammatory bowel disease, hyperparathyroidism, and history of low vitamin D levels. Updates were made throughout the package insert detailing clinical trial data evaluating the safety and effectiveness in adult and pediatric patients. These details were added to the patient information stating that INJECTAFER is used for the treatment of iron deficiency in adults with mild to moderate heart failure to improve the ability to exercise (improve exercise capacity). It is not known if INJECTAFER is safe and effective in children with iron deficiency and mild to moderate heart failure to improve exercise capacity. Additional allergic reactions and common side effects in adults and children were added to the drug materials including dizziness or lightheadedness, feet or hands turn blue, loss of consciousness, trouble breathing, rash, swelling, fast heartbeat, low levels of blood phosphate, headache, injection site reactions and vomiting.
ZINPLAVA (BEZLOTOXUMAB) The Adverse Reactions section of the PI was updated to detail clinical trial data of reported adverse reactions in adults. Additional information was included detailing the safety, effectiveness and pharmacokinetics when used in pediatric patients 1 year of age and older. Adverse reactions observed in pediatric patients were comparable to those observed in adult patients. The safety and effectiveness of ZINPLAVA have not been established in pediatric patients younger than 1 year of age.
SEMGLEE (INSULIN GLARGINE-YFGN) The Adverse Reactions section of the PI was updated to detail risk of hypoglycemia due to medication errors. The Use in Specific Populations section was updated to include clinical trial data when the medication is used in Pregnancy, Pediatric and Geriatric patients. Additional patient counseling information was included to detail separate Instructions for Use for the vial and prefilled pen.
KABIVEN and PERIKABIVEN (amino acids, electrolytes, dextrose and lipid injectable emulsions) - The Contraindications, Warnings and Precautions, Adverse Reactions and Use in Specific Populations sections of the PI as well as the Patient Counseling Information were updated to detail reporting of serious adverse reactions including acute respiratory distress, metabolic acidosis, and death in neonates and infants after rapid infusion of intravenous lipid emulsions. Additionally, hypertriglyceridemia was commonly reported.
BRIVIACT (BRIVARACETAM) The Use in Specific Populations section of the PI was updated detailing insufficient study data to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes when the medication is used during pregnancy. Additionally, data from published literature indicates that brivaracetam is present in human milk. There is insufficient information on the effects of brivaracetam on the breastfed infant or on milk production.
VIDAZA and Generics (AZACITIDINE) The Warnings and Precautions section of the PI was updated to include substantial differences in the pharmacokinetic parameters between oral and injectable formulations. Sections were updated throughout indicating that the Pediatric Use Information is approved for Celgene Corporation’s Vidaza® (azacitidine for injection) and not included in alternate manufactured products due to Celgene Corporation’s marketing exclusivity rights.
PREVYMIS (LETERMOVIR) Extensive changes were made in the Adverse Reactions section of the PI detailing clinical trial data and findings. The Patient Information was updated stating the most common side effect of PREVYMIS in adults who have received a kidney transplant is diarrhea.
VEKLURY (REMDESIVIR) The Use in Specific Populations section of the PI was updated detailing study data when used in Pregnancy or Lactation. One study evaluating the pharmacokinetics of remdesivir during pregnancy demonstrated no clinically relevant differences between pregnant and non-pregnant individuals. No dose adjustments are recommended in patients who receive VEKLURY during pregnancy. The package insert was updated to state it is not known if VEKLURY may harm an unborn baby if taken during the first trimester of pregnancy. Data from pharmacovigilance reports does not indicate adverse effects on breastfed infants from exposure to remdesivir and its metabolite through breastmilk. There is no available data on the effects of remdesivir on milk production.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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