Varubi Injectable Emulsion Causing Anaphylaxis, Other Hypersensitivity Reactions, FDA Warns

Published on January 17, 2018 by Sandy Liebhard

Tesaro, Inc. is updating the prescribing information for Varubi injectable emulsion, following reports linking the anti-nausea medication to anaphylaxis, anaphylactic shock and other serious hypersensitivity reaction, including some cases that required patients to be hospitalized.

What is Varubi Injectable Emulsion?

Varubi (rolapitant) is approved to prevent nausea and vomiting in adults who are being treated with emetogenic chemotherapy.

Varubi tablets were initially cleared by the U.S. Food & Drug Administration (FDA) in September 2015.  Varubi injectable emulsion, which is administered intravenously, only received FDA approval in October 2017.

Tesaro has indicated that more than 7,000 doses of Varubi injectable emulsion have been administered since its launch. Overall, the company reported $7.4 million in Varubi sales during the first 9 months of 2017.

Varubi: What’s the Problem?

According to an FDA Drug Safety Communication dated January 16, 2018, anaphylaxis, anaphylactic shock and other serious hypersensitivity reaction associated with Varubi injectable emulsion have occurred during or soon after infusion, with most occurring within the first few minutes of administration.

Symptoms include:

• Wheezing or difficulty breathing
• Swelling of the face or throat
• Hives or flushing
• Itching
• Abdominal cramping
• Abdominal pain or vomiting
• Back pain or chest pain
• Hypotension or shock

FDA Recommendations

The FDA is advising healthcare providers to:

• Be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi injectable emulsion, both during and following Varubi administration.
• Consult with patients to determine if they are hypersensitive to any component of the product (including soybean oil).
• Monitor patients closely if they have allergies to legumes or other related allergens.

If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs:

• Administration of Varubi injectable emulsion should be stopped immediately.
• Appropriate medical management (including epinephrine and or antihistamines) should be initiated,
• Varubi injectable emulsion should be permanently discontinued.

Adverse events possibly associated with Varubi injectable emulsion can be reported to Tesaro at 1-844-4-TESARO (1-844-483-7276).

Side effects associated with this or any other prescription drug may also be reported to the FDA at www.fda.gov/medwatch, or by calling 1-800-FDA-1088