modified ragweed tyrosine adsorbate

Modified ragweed tyrosine adsorbate is a vaccine used to prevent or reduce symptoms of immunoglobulin E (IgE) mediated allergic reactions (rhinitis) to ragweed pollen. Ragweed is a genus of flowering plants belonging to the aster family native to North America. Ragweed pollen is typically shed in late summer and fall and in mid-September, the pollen reaches peak levels. Ragweed pollen allergy is a major cause of hay fever in many people, with symptoms that include runny and congested nose, sneezing, itchy throat, headache and watering eyes.

Modified ragweed tyrosine adsorbate is prepared with the purified extract of the pollen of a ragweed plant species (Ambrosia elatior) and modified to reduce its allergy-causing ability, while retaining its ability to induce immune response. It is not clear how the vaccine works exactly, but studies show that introducing a small amount of the ragweed pollen causes the immune system to produce antibodies (immunoglobulin G [IgG]) against the pollen, suppressing IgE antibodies, which possibly reduces the recipient’s allergic reactions to the ragweed pollen.

Modified ragweed tyrosine adsorbate is administered as a subcutaneous injection into the tissue under the skin. The vaccine is given in 4 doses starting from the end of June to complete by the first week of August, and should not be administered during the ragweed pollen season which starts in mid-August and lasts until late September. A skin test with the allergen extract is first performed and the dosage is individualized based on the person’s sensitivity and response. 

• Do not administer modified ragweed tyrosine adsorbate to anyone with hypersensitivity to any component of the formulation.
• Do not administer modified ragweed tyrosine adsorbate to anyone who has had a previous severe anaphylactic reaction to ragweed vaccine immunotherapy.
• Do not administer modified ragweed tyrosine adsorbate to individuals who do not show skin test reactions and clinical sensitivity to ragweed.
• Do not use modified ragweed tyrosine adsorbate in people with any of the following:
  • Conditions or diseases that prevent treatment of possible anaphylactic reactions, such as chronic heart or lung disease, or severe arterial hypertension
  • Diseases marked by susceptibility to bleeding and/or bruising
  • Pathologic immune conditions
  • Unstable or severe chronic or severe seasonal asthma
• Do not administer modified ragweed tyrosine adsorbate to patients taking:
  • Beta blocker treatment, because they may be more prone to anaphylaxis and may not be responsive to conventional treatment such as epinephrine or inhaled bronchodilators.
  • ACE inhibitors, because they may cause more severe anaphylactic reactions.
  • Monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, because they may enhance the effects of epinephrine used to treat anaphylaxis and increase the risk of irregular heart rhythm (arrhythmia).
• In patients who have had fever or an acute infection, do not administer modified ragweed tyrosine adsorbate until 24 to 48 hours after the patient has become normal.
  • Modified ragweed tyrosine adsorbate can cause severe immediate or delayed, life-threatening reactions including anaphylactic shock.
  • Modified ragweed tyrosine adsorbate treatment should be carried out only by or under the supervision of physicians experienced in specific immunotherapy in a facility with equipment, medications, including epinephrine, and trained personnel to treat severe anaphylactic reactions, should they occur.
  • Modified ragweed tyrosine adsorbate should be administered only subcutaneously. Exercise care to avoid injecting into blood vessels.
  • Advise patients to avoid known co-factors to anaphylaxis such as alcohol and strenuous exercise on the injection day, and not to consume a heavy meal immediately before receiving the injection.
  • Pretreat with antihistamines about one hour before administering the vaccine.
  • Monitor patients for at least 30 minutes following administration of modified ragweed tyrosine adsorbate. If a patient experiences even mild reactions, monitor until symptoms are resolved. If severe reactions occur, treat appropriately and consider risks and benefits of treatment continuation.
  • Patients with asthma are more likely to experience severe reactions.
  • Instruct individuals on the procedure for emergency self-injection of epinephrine before initiating modified ragweed tyrosine adsorbate vaccine course.
  • Educate patients on the symptoms of severe allergic reactions and advise them to seek immediate medical care at the first sign of such symptoms.
• Do not administer modified ragweed tyrosine adsorbate concurrently with viral or bacterial pathogen vaccines, it can reduce the efficacy of the viral or bacterial vaccines, and in addition, safety of concomitant administration has not been evaluated.
• Safety of modified ragweed tyrosine adsorbate has not been established in patients with impaired pulmonary function. Concomitant use of symptomatic anti-allergic treatments such as antihistamines, corticosteroids or mast cell degranulation inhibitors may mask the patient’s current reactivity status.
• Closely monitor high-risk patients such as those with a high level of sensitization, during the course of modified ragweed tyrosine adsorbate treatment.

Common side effects of modified ragweed tyrosine adsorbate include:

• Injection site reactions including:
  • Warmth
  • Swelling
  • Redness (erythema)
  • Hives (urticaria)
  • Itching (pruritus)
  • Pain
  • Hardening of tissue (induration)
  • Discoloration
  • Hematoma
• Throat tightness
• Throat irritation
• Nasal congestion
• Nasal discharge (rhinorrhea)
• Sinus congestion
• Shortness of breath (dyspnea)
• Nausea
• Diarrhea
• Abdominal discomfort
• Abdominal pain
• Generalized urticaria
• Generalized pruritus
• Eye swelling
• Chest discomfort
• Chills
• Increase in body temperature

Rare side effects of modified ragweed tyrosine adsorbate include:

• Severe allergic reactions (anaphylactic shock) with symptoms including:
  • Tingling, itching and burning sensations in:
    • Mouth
    • Tongue
    • Throat
    • Palms
    • Soles
  • Restlessness
  • Anxiety
  • Urticaria
  • Nausea
  • Vomiting
  • Low blood pressure (hypotension)
  • Rapid heart rate (tachycardia)
  • Dizziness
  • Voice box swelling (laryngeal edema)
  • Bronchospasm
  • Shortness of breath
  • Bluish skin from drop in oxygen saturation level
  • Loss of consciousness
  • Cardiac and respiratory arrest

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Prefilled syringes

• Each patient treatment package consists of 4 prefilled sterile syringes each containing 0.5 mL of suspension. Each syringe is labeled as to syringe number and strength in total Protein Nitrogen Units. Contains phenol as preservative.

Vials

• Each patient treatment package consists of 4 sterile vials each containing 1 mL of suspension. Each vial is clearly labeled as to vial number and strength in total Protein Nitrogen Units. Contains phenol as preservative.

Adult and Pediatric:

Ragweed allergic rhinitis

• The pre-seasonal immunotherapy of ragweed allergic rhinitis in adults and children, over the age of 8 years
• The safety and effectiveness have not been established for children under 8 years of age.
• Modified ragweed tyrosine adsorbate should be administered as a course of four 0.5 ml subcutaneous injections. One 300 NU/0.5 ml injection, one 700 NU/0.5 ml injection, one 2000 NU/0.5 ml injection and one 6000 NU/ 0.5 ml injection must be administered prior to the pollen season with a recommended interval of 7 days between injections. At each strength, the maximum injection of 0.5 ml must not be exceeded.
• The injections should be started by the end of June. The injections are given at 7-day intervals so the last has been used by the beginning of August.

Geriatric:

• The safety and efficacy of modified ragweed tyrosine adsorbate use in geriatric populations has not been established. Patients over 60 years of age may have an increased risk of impaired cardiovascular and/or pulmonary function.

Dosing considerations

• Modified ragweed tyrosine adsorbate administration should not be instituted unless other ragweed pollen extract therapy has been discontinued.
• Safety for the use of modified ragweed tyrosine adsorbate in combination with other allergens has not been established.
• The dosage of allergenic extracts is a highly individualized matter and varies according to the degree of sensitivity of the patient, their clinical response and tolerance to the extract administered during the early phases of an injection regimen. The starting dose should be based on skin tests of the extract to be used for immunotherapy.

Storage

• The injections should be kept in the refrigerator between 2 to 8°C until they are needed. The syringe that will be used should be allowed to come to room temperature before it is used.

Overdose

Modified ragweed tyrosine adsorbate overdose can intensify the vaccine’s side effects and increase the risk of severe systemic reactions. Overdose must be treated immediately with appropriate supportive care required to manage severe allergic reactions.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of modified ragweed tyrosine adsorbate include:
  • beta blockers
  • immunosuppressant therapy
  • angiotensin-converting enzyme (ACE) inhibitors
  • monoamine oxidase inhibitors (MAOIs)
  • tricyclic antidepressants
• Modified ragweed tyrosine adsorbate has no listed serious interactions with other drugs.
• Moderate interactions of modified ragweed tyrosine adsorbate include:
  • hyposensitization therapy
  • symptomatic anti-allergic agents such as histamines
  • viral or bacterial pathogen vaccines
• Modified ragweed tyrosine adsorbate has no listed mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no data on the use of modified ragweed tyrosine adsorbate in pregnant women. Do not initiate treatment in pregnant women because it may cause severe systemic reactions which may harm the fetus.
• There is no information on the use of modified ragweed tyrosine adsorbate in breastfeeding women. It is not known if the vaccine is present in breastmilk.

• Do not rub the injection site after receiving modified ragweed tyrosine adsorbate injection.
• Do not consume a heavy meal immediately before your appointment for modified ragweed tyrosine adsorbate injection.
• Do not drink alcohol or do strenuous exercise on the day of the injection.
• Inform the physician if you have had a recent acute infection or fever, the vaccine cannot be administered for 24 to 48 until after your return to normal condition.
• Inform your physician and seek immediate medical care if you experience allergic reactions such as tingling, itching and burning in the mouth, tongue, throat, palms and soles, dizziness, hives, nausea, vomiting, and breathing difficulty, following administration of modified ragweed tyrosine adsorbate.