To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
INTRALIPID 10%, 20%, 30% The Warnings and Precautions section of the Approved Drug Label (ADL) was updated regarding Hypersensitivity Reactions stating that Intralipid contains soybean oil and egg phospholipids, which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. In postmarketing experience, anaphylaxis has been reported following Intralipid administration. Intralipid is contraindicated in patients with known hypersensitivity to egg, soybean, peanut or any of the active or inactive ingredients in Intralipid. Monitor patients during and after infusion. If a hypersensitivity reaction occurs, stop infusion of Intralipid immediately and initiate appropriate treatment and supportive measures. The Adverse Reactions section was further updated to reflect this information.
SMOFLIPID 20% The Warnings and Precautions section of the Approved Drug Label (ADL) was updated regarding Hypersensitivity Reactions stating that in postmarketing experience, anaphylaxis has been reported following SMOFlipid administration. The Patient Counseling Information was updated stating if SMOFlipid is infused at home, instruct patients or caregivers to stop the infusion of SMOFlipid immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing, dizziness, fever, or chills.
OMEGAVEN (FISH OIL TRIGLYCERIDES) The Warnings and Precautions and Adverse Reactions sections of the Approved Drug Label (ADL) were updated regarding Hypersensitivity Reactions stating that in postmarketing experience, anaphylaxis has been reported following Omegaven administration. Omegaven is contraindicated in patients with known hypersensitivity to fish or egg protein or to any of the active or inactive ingredients in Omegaven. The following adverse reactions have been identified during post-approval use of Omegaven. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Updated information includes hematologic system disorders of hemorrhage, and immune system disorders of hypersensitivity reactions, including anaphylaxis. The Patient Counseling Information was updated stating if Omegaven is infused at home, instruct caregivers to stop the infusion of Omegaven immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing, dizziness, fever, or chills.
CEFEPIME IN PLASTIC CONTAINER (CEFEPIME HYDROCHLORIDE) The Adverse Reactions section of the ADL was updated to include a fall in prothrombin activity.
CUPRIC CHLORIDE IN PLASTIC CONTAINER The Warnings and Precautions section of the ADL was updated regarding Hepatic Accumulation. This section now states that Copper is primarily eliminated in the bile and excretion is decreased in patients with cholestasis and/or cirrhosis. Hepatic accumulation of copper has been reported in autopsies of patients receiving long-term parenteral nutrition containing copper at dosages higher than recommended. Administration of copper to patients with cholestasis and/or cirrhosis may cause hepatic accumulation of copper. Administration of copper to patients with Wilson disease, an inborn error of copper metabolism with a defect in hepatocellular copper transport, may cause both increased hepatic accumulation of copper and aggravation of the underlying hepatocellular degeneration. For patients with cholestasis, biliary dysfunction, or cirrhosis, monitor hepatic and biliary function during long-term administration of Cupric Chloride Injection. If a patient develops signs or symptoms of hepatobiliary disease during the use of Cupric Chloride Injection, obtain serum concentrations of copper and ceruloplasmin, and adjust the dose as indicated. Regarding Hypersensitivity Reactions, the ADL now states that postmarket safety reporting has identified copper hypersensitivity in women receiving copper-containing intrauterine devices, providing evidence that patients may experience hypersensitivity reactions when exposed to this metal. If hypersensitivity reactions (e.g., pruritis, angioedema, dyspnea, rash, urticaria) occur in patients receiving Cupric Chloride Injection in parenteral nutrition, discontinue the product, and initiate appropriate medical treatment. Aluminum Toxicity was added. The Use in Specific Populations, Pediatric Use section was updated to state that the safety and effectiveness of Cupric Chloride Injection have been established in pediatric patients receiving parenteral nutrition. The updated details for Hepatic Accumulation were also included in a new subsection for Hepatic Impairment.
HUMIRA (ADALIMUMAB) The ADL was updated extensively regarding the following topics and inclusions: Autoimmunity - autoimmune hepatitis, Pediatric Use – stating the safety and effectiveness of HUMIRA have not been established in pediatric patients with psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis, Juvenile Idiopathic Arthritis - the safety and effectiveness of HUMIRA for the treatment of moderately to severely active polyarticular JIA have been established in pediatric patients 2 years of age and older and use for this indication is supported by evidence from an adequate and well-controlled study, Pediatric Uveitis - The safety and effectiveness of HUMIRA for the treatment of non-infectious, intermediate, posterior, and panuveitis have been established in pediatric patients 2 years of age and older and use of HUMIRA for this indication is supported by evidence from adequate and well-controlled studies of HUMIRA in adults and a 2:1 randomized, controlled clinical study in 90 pediatric patients, Hidradenitis Suppurativa -
use of HUMIRA in pediatric patients 12 years of age and older for the treatment of moderate to severe HS is supported by evidence from adequate and well-controlled studies of HUMIRA in adult HS patients. The Patient Counseling Information and Medication Guide were updated regarding Hypersensitivity Reactions stating to advise latex-sensitive patients that the needle cap of the HUMIRA 40 mg/0.8 mL Pen and 40 mg/0.8 mL, 20 mg/0.4 mL and 10 mg/0.2 mL prefilled syringe may contain natural rubber latex. The black needle cover for the HUMIRA Pen 80 mg/0.8 mL, HUMIRA 80 mg/0.8 mL prefilled syringe, HUMIRA Pen 40 mg/0.4 mL, HUMIRA 40 mg/0.4 mL prefilled syringe, HUMIRA 20 mg/0.2 mL prefilled syringe, HUMIRA 10 mg/0.1 mL prefilled syringe and the vial stopper on the HUMIRA institutional use vial are not made with natural rubber or latex.
KABIVEN IN PLASTIC CONTAINER (AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL)
PERIKABIVEN IN PLASTIC CONTAINER (AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL)
The Warnings and Precautions, Hypersensitivity Reactions and Adverse Reactions sections of the ADL were updated stating that in postmarketing experience, anaphylaxis has been reported following administration. Immune system disorders: hypersensitivity reactions, including anaphylaxis was included throughout. The Patient Counseling Information was also updated to state if infused at home, instruct patients or caregivers to stop the infusion immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing, dizziness, fever, or chills.
COLY-MYCIN M (COLISTIMETHATE SODIUM) The Warnings and Precautions section of the ADL was updated regarding Electrolyte and Acid/Base Abnormalities stating that postmarketing cases of renal tubulopathy (i.e., Pseudo-Bartter syndrome) have been identified with the use of intravenous colistimethate sodium. All cases reported hypokalemia and metabolic alkalosis. Other common findings included hypocalcemia, hypomagnesemia, increased potassium in the urine, normal serum creatinine, and normal blood pressure. Consider electrolyte monitoring during treatment. Normalization of electrolyte abnormalities may require drug discontinuation. The Adverse Reactions section was updated regarding the Renal System to include electrolyte and acid/base abnormalities (i.e., Pseudo-Bartter syndrome).
DEXTROSE 25%, 50% The Contraindications section of the ADL was updated to state that Dextrose Injection (25%, 50%) is contraindicated in patients with intracranial or intraspinal hemorrhage because Dextrose Injection (25%, 50%) can worsen cerebral edema by causing a fluid shift across the blood-brain barrier, severe dehydration because of the potential to worsen the patient’s hyperosmolar state and known hypersensitivity to dextrose. The Adverse Reactions section was updated stating that the following clinically significant adverse reactions are also described elsewhere in the labeling: Hyperglycemia and Hyperosmolar Hyperglycemic State, Hypersensitivity Reactions, Phlebitis and Thrombosis, Electrolyte Imbalance and Fluid Overload, and Hyponatremia. The following adverse reactions associated with the use of Dextrose Injection were identified in clinical trials or postmarketing reports and because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure - Administration site conditions: blister, extravasation, phlebitis, erythema, pain, vein damage, thrombosis; Immune system disorders: anaphylaxis, angioedema, bronchospasm, chills, hypotension, pruritis, pyrexia, rash; Cardiovascular disorders: cyanosis, volume overload. Subsections throughout the ADL were created and updated to comply with Physician Labeling Rule (PLR); please refer to label for complete information.
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER The Warnings and Precautions, Hypersensitivity Reactions section of the ADL was updated to include acute myocardial ischemia with or without myocardial infarction. The Adverse Reactions, Postmarketing Experience section was updated to include Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions) and acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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