The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by united states food and drug administration (FDA) that Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the post marketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Symptoms of anaphylaxis may include wheezing or difficulty in breathing, swelling of the face or throat, hives or flushing, itching,abdominal cramping or vomiting, back pain or chest pain, hypotension or shock.
Varubi (rolapitant) injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adult in combination with other drugs (antiemetic) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing cancer chemotherapy.
Recommended Action
- Health care professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving Varubi (rolapitant) injectable emulsion, both during and following its administration.
- It is advised that health care professionals consult with patients to determine if they are hypersensitive to any component of the product including soy beans.
- Patients with known allergies to legumes or other related allergens should be monitored closely.
- Patient with known hypersensitivity should not be administered Varubi (rolapitant) injectable emulsion.
- Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with Varubi (rolapitant) injectable emulsion.
- If anaphylaxis or any other serious hypersensitivity /infusion reaction occurs, appropriate medical management should be initiated and Varubi should be permanently discontinued.
- Healthcare providers and patients are encouraged to report adverse reactions associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
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