April 24, 2014 -- As many as 4 in 10 Americans have sneezing, runny nose, and watery eyes due to allergies. If you’re one of them, allergy shots can help ease your reaction to the plants, insects, or animals that trigger your symptoms. But they require multiple doctor visits over years.
That’s one reason only about 5% of Americans with allergies get the shots, even though they can provide long-lasting relief, says Linda Cox, MD, of the American Academy of Allergy, Asthma, and Immunology. The rest rely on avoiding whatever triggers their allergies, which isn’t always easy. Or they use antihistamines and steroid nose sprays to temporarily ease symptoms.
But now allergic people have a new option: under-the-tongue tablets they can take at home. The prescription tablets, called Grastek, Ragwitek, and Oralair, are the first allergy treatments of their kind on the U.S. market, although they’ve been available in Canada and Europe. All three medications were approved by the FDA this month.
The tablets contain the same type of extracts used in allergy shots. As with the shots, the goal is to boost a patient’s tolerance of allergy triggers.
“People still need to see an allergist,” says Sandra Lin, MD, associate professor otolaryngology-head and neck surgery at Johns Hopkins. “The first thing to know is what you’re allergic to.”
Cox and Lin address common questions about the new tablets and other allergy treatments.
Q: What types of allergies do the tablets target?
A: Grastek contains an extract from Timothy grass, commonly known as cat’s tail. It is found in all 50 states as well as most of Canada, according to the U.S. Department of Agriculture. Oralair contains extracts from Timothy grass plus sweet vernal, orchard, perennial rye, and Kentucky bluegrass. Ragwitek contains an extract from short ragweed.
Q. What are the advantages and disadvantages of the tablets compared to allergy shots?
A. One of the main advantages of the tablets is convenience, Lin and Cox say. Shots are given in a doctor’s office. It starts with once or twice a week for 3 to 6 months, then once or twice a month for 3 to 5 years, according to the American Academy of Allergy, Asthma, and Immunology. Some people have fewer symptoms for years after they finish the shots, Lin says. Those who get symptoms again might need more shots.
One drawback of the tablets is that they might not cover everything people are allergic to, Lin says. Shots can be tailored to a person's needs. “In the United States, a lot of people are sensitive to more than one thing,” she says.
Q. How long do you have to take these tablets?
A. Grastek’s label says you should begin taking the tablets 8 to 12 weeks before and then during the pollen season. Grastek may be taken for up to 3 years.
Oralair’s label says you should start taking the tablets 4 months prior to and through the pollen season. Ragwitek’s label says you should begin treatment 12 weeks before and then during the pollen season.
Some studies suggest that people with allergies who take the tablets only during pollen season still benefit, Cox says.
With all three pills, you’re supposed to take the first tablet in your doctor’s office in case you have a severe reaction. Such a reaction, called anaphylaxis, is thought to be less likely with the tablets than with the shots. But because anaphylaxis can happen later with the tablets, the labels call for patients to have injectable epinephrine at home to treat it. Epinephrine can slow down or stop the reaction.
Q: What about other side effects?
A. For Grastek and Oralair, the most common side effects are an itchy mouth, throat irritation, and mouth swelling. Side effects for Ragwitek include mouth itching, and ear and throat irritation.
Q. Can children take Oralair, Grastek or Ragwitek?
A. Oralair is approved for ages 10 to 65, while Grastek is approved for ages 5 to 65. Ragwitek is approved only for adults ages 18 to 65.
Q. How much do the tablets cost?
A. The wholesale price of both Grastek and Ragwitek will be $8.25 per pill, or $247.50 for a 30-day supply, says Merck spokeswoman Pamela Eisele. The wholesale price of Oralair will be $10 per pill, or $300 for a 30-day supply, says Andrea Moody, a spokeswoman for Greer Laboratories, which is marketing the drug in the United States.
Both Eisele and Moody note that actual costs will vary, depending on your insurance coverage. Allergy shots cost about $25 each.
Q. Even before Oralair, Ragwitek, and Grastek became available, weren’t some U.S. doctors using similar treatments for allergies?
A. Doctors have been using under-the-tongue drops for “off-label” use. Off-label means a medication is being used in a way not specified in the FDA's approved packaging label.
A 2011 survey by the American College of Allergy, Asthma, and Immunology found that more than 11% of those polled said they used under-the-tongue drops, nearly double the percentage from a 2007 survey. The drops have the same extracts used in allergy shots.
Lin says she mixes the extracts according to patients’ allergy test results. She sends them home with a metered vial so they know how much to take each day. There is no standard dose; Lin says she bases the size of the doses on research published by European doctors. Cox says she hasn’t prescribed the drops because “we don’t know what the effective dose would be.”
Q. What if you don’t like to get a bunch of shots or have to remember to take medicine every day? What’s on the horizon?
A. How about four monthly shots? Period. That’s all it took for an experimental treatment for cat allergies to protect against symptoms 2 years after the first shot. The treatment, developed by researchers at McMaster University in Canada, is in its final stage of pre-market testing. The scientists are also working on a similar approach to treat ragweed and dust mite allergies.
Cox has served as a consultant for Stallergenes, the French company that markets Oralair.