Varubi, a drug to treat nausea and vomiting after chemotherapy, has been linked to serious allergic reactions.
The medication, made by Boston-based Tesaro, comes in oral tablets and in liquid for intravenous use. The active ingredient is called rolapitant.
The U.S. Food and Drug Administration approved Varubi tablets in 2015 and injections in 2017.
On January 16, 2018, the FDA warned that Varubi may cause allergic reactions minutes after being administered intravenously. Some patients required hospitalization.
Tesaro sent a warning letter to health care providers in January 2018. Doctors administered about 7,000 doses of the IV drug from October 2017 to January 2018, according to Tesaro.
Since then, Varubi lawyers have started filing class action lawsuits for Tesaro shareholders. Tesaro knew the drug could cause allergic reactions and failed to disclose the risk, lawyers say.
Lawyers may also be investigating individual Varubi allergic reaction injury claims.
How Varubi Works
Varubi works by blocking receptors in the body that play a role in vomiting and nausea. These receptors are called neurokinin (NK)-1 receptors.
(NK)-1 receptors are located in the brain stem. Varubi crosses the blood-brain barrier and covers the receptors. Doctors use Varubi with other medications to treat nausea and vomiting caused by chemotherapy.
Varubi belongs to a class of drugs called (NK)-1 receptor antagonists. Another drug in the same class is Emend, manufactured by Merck.
Varubi Side Effects
The most serious Varubi side effects reported are anaphylaxis and anaphylactic shock with intravenous Varubi. These are types of allergic reactions.
These side effects can occur within minutes after receiving intravenous Varubi. Most people who suffered these side effects had to go to the hospital.
Less serious Varubi side effects may vary depending on the type of chemotherapy a patient receives. These may occur with oral or intravenous Varubi. Some are immediate, while others may surface later.
- difficulty breathing
- swelling of the throat or face
- hives or flushed skin
- abdominal pain
- back or chest pain
- neutropenia (susceptibility to infections)
- abdominal pain
- decreased appetite
- dyspepsia (indigestion)
- urinary tract infection
- stomatitis (mouth sores)
Varubi FDA Warnings
On January 16, 2018, the FDA released a safety communication warning that Varubi infusions could lead to serious hypersensitivity reactions such as anaphylaxis and anaphylactic shock.
These reactions occurred during or soon after an infusion of Varubi, according to the FDA. Most reactions occurred within a few minutes of receiving the drug.
One of the ingredients in Varubi is soybean oil. People allergic to soybeans should tell their doctor before using Varubi.
Tesaro announced changes to the drug’s label to add this information on January 12, 2018.
Varubi Dosages, Recommendations and Costs
Patients receive Varubi with other types of anti-nausea drugs. They receive the first dose two hours before starting chemotherapy on the first day.
For tablets, the recommended dose is 180 mg. For an injection, the dose is 166.5 mg in an intravenous infusion over 30 minutes.
The average cost of Varubi is about $560 for two tablets. Intravenous Varubi costs about $295 for one ready-to-use vial. The price may change depending on insurance plans.
Varubi stays in the body for seven days, longer than a cheaper drug in the same class. Emend, another (NK)-1 receptor antagonist, costs about $130 for one pill.
Varubi Drug Interactions
Varubi interacts with drugs that increase or decrease levels of an enzyme in the body called CYP2D6. Many antidepressants interact with this enzyme.
Patients taking thiorodazine or pimozide should not take Varubi. Taking these drugs together may lead to life-threatening abnormal heart rhythms.
Alternatives to Varubi
People who cannot take Varubi may try other drugs to treat chemotherapy-induced nausea and vomiting.
For example, other drugs in the same class include Emend and Akynzeo. Other drugs for nausea include Taxotere, metoclopramide and chlorpropamide.
Other options used to control nausea are drugs that mimic the effects of cannabis. These drugs are called synthetic cannabinoids. These include Marinol (dronabinol) and Cesamet (nabilone).
These drugs have their own side effects. Patients should talk to their doctors before taking these medications.
Varubi Lawsuit and Class Action
Robert Bowers filed a class-action complaint in Massachusetts against Tesaro and some of its officers on January 17, 2018.
The complaint alleged Tesaro failed to disclose the risk of anaphylaxis and anaphylactic shock. This led to artificially inflated stock prices.
After the FDA released the side-effect warning, stock prices fell by about $4.07. As a result, “class members suffered significant loses and damages,” the complaint said.
Lawyers may also be accepting individual cases from patients who suffered anaphylaxis and anaphylactic shock after taking Varubi.
Please seek the advice of a medical professional before making health care decisions.