Pollinex-R ()

POLLINEX®-R

Bencard

Modified Ragweed Tyrosine Adsorbate

Vaccine

Action And Clinical Pharmacology: Pollinex-R is an aqueous extract of short ragweed pollen (Ambrosia elatior) chemically modified with gluteraldehyde adsorbed onto tyrosine and then suspended in saline.

The exact mode of therapeutic action of Pollinex-R, as with other allergy vaccines, is unknown. It has been proposed the elevation of IgG blocking antibodies may interfere with the immediate hypersensitivity reaction of patients exposed to ragweed pollen. In addition, patients receiving Pollinex-R have lesser postseasonal increase in ragweed specific IgE antibody compared to placebo treated patients. It is possible that suppression of IgE antibody by Pollinex-R during the ragweed season could influence the response of ragweed allergic patients to the pollen in their environment.

Indications And Clinical Uses: For the preseasonal immunotherapy of adults and children, over 8 years of age, who have demonstrated ragweed allergic rhinitis by careful patient history and physical examination, supplemented by skin testing and/or immunological assay.

Pollinex-R is generally not expected to completely eliminate the various allergic symptoms but should reduce their severity. Pollinex-R should also be expected in many patients to reduce their dependence on other medication, such as antihistamines and other cough/cold over the counter medications that are taken during the season to alleviate rhinitis symptoms. There is evidence the use of more potent therapy, such as nasal and oral steroids, is reduced in patients who have received a course of Pollinex-R.

Contra-Indications: Pollinex-R should not be administered to a patient who has experienced a previous severe anaphylactic reaction to ragweed vaccine immunotherapy.

Manufacturers’ Warnings In Clinical States: Patients suffering from febrile conditions or an acute asthmatic attack should not be given Pollinex-R until 24 hours after their condition has returned to normal. Acute immediate anaphylactic reactions characterized by difficulty in breathing, cyanosis and shock have rarely occurred with Pollinex-R treatment, but if such should occur, standard emergency measures must be adopted with the use of a tourniquet above the injection site, epinephrine, oxygen, i.v. steroids and airway management including intubation if required. Similarly, delayed anaphylactic reactions have rarely been reported with Pollinex-R, however, the patient should be advised to report to their physician immediately if symptoms of such a reaction should be manifested.

Recent evidence suggests that patients on beta-blockers may be more prone to anaphylaxis during immunotherapy and in such patients, anaphylaxis may be less responsive to conventional treatment.

Hence, in such patients, the need for continued immunotherapy and/or continued beta-blocker use should be carefully reviewed.

Do not administer Pollinex-R during the ragweed season, which usually starts in mid-August through to the end of September, or until the first killing frost.

Precautions: All Pollinex-R administrations must be given by the s.c. route, by or under a physician’s supervision. Never inject Pollinex-R directly into a blood vessel.

All patients should remain under observation in the doctor’s office or clinic for 20 to 30 minutes after each vaccine injection and then should avoid strenuous physical exercise for at least 24 hours.

Advise patients not to eat a heavy meal immediately before receiving their Pollinex-R injection. It is advisable to administer an antihistamine about 1 hour prior to a Pollinex-R injection. Epinephrine HCl 1:1 000 solution should always be kept on hand for use in the very unlikely event of a severe immediate reaction.

It is extremely important to shake the syringe containing the vaccine prior to injection thus greatly reducing the possibility of needle blockage.

Pregnancy: Pollinex-R’s safety for use in pregnancy has not been established.

Safety for use in combination with other allergens has not been established. Pollinex-R administration should not be instituted unless other ragweed pollen extract therapy has been discontinued.

Adverse Reactions: Hypersensitivity: erythema, swelling, pruritus, wheal, papule, mild hives, anaphylactoid reaction.

Other: local reactions, such as pain accompanied by induration at the injection site; wheezing, stuffy and/or runny nose, tight chest.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: It is not possible to administer to a patient an overdosage of Pollinex-R, as long as no more than 0.5 mL of the vaccine is administered starting with either syringe or vial number 1, followed in sequence by syringe or vial 2, 3 and lastly 4.

In patients with severe allergic reactions, general supportive measures (if the patient is in shock) or symptomatic therapy similar to that applied in all cases of hypersensitivity are recommended. Pressor amines, antihistamines and corticosteroids should be readily available. Pollinex-R is not suitable for such patients with severe allergic reactions.

Dosage And Administration: Pollinex-R must be given prior to the ragweed season which usually starts in mid August. The course of vaccine therapy should start toward the end of June and be given so that the last injection is received about the first week in August.

Syringes: Each course of Pollinex-R consists of a patient treatment pack of 4 sterile prefilled syringes clearly labeled 1, 2, 3 and 4 containing the following Pollinex-R strengths each in a 0.5 mL volume.

The vaccine treatment regimen consists of the administration of Pollinex-R by s.c. injection. On the first occasion, the contents of No. 1 syringe are given, followed in order by syringe numbers 2, 3 and 4 at a recommended interval of approximately 7 days between injections. The operation of the syringe is as follows:

1. Withdraw the syringe from the cold storage condition well before time of administration and allow to attain room temperature. Do not heat.

2. Do not remove the needle guard until ready for use.

3. Withdraw syringe plunger slightly and shake the syringe thoroughly to ensure a homogeneous suspension.

4. Apply quick firm pressure on the plunger to burst internal seal (the rupture will be felt).

5. Release the pressure in the syringe by withdrawing the plunger slightly.

6. Shake the syringe thoroughly again, remove needle guard, then carefully express the air from the syringe with the needle held upwards, to minimize loss of contents.

7. Slowly inject the suspension deep subcutaneously.

8. Do not inject into a blood vessel.

Vials: Each patient treatment pack consists of 4 sterile vials clearly labeled 1, 2, 3 and 4 containing Pollinex-R strengths each in a volume of 1 mL as seen in Table II.

The vaccine treatment regimen consists of the administration of Pollinex-R by s.c. injection. On the first occasion, 0.5 mL of the contents of No. 1 vial are given, followed in order by 0.5 mL of vial numbers 2, 3 and 4 at a recommended interval of approximately 7 days between injections.

Procedure for vials:

1. Withdraw the vial from the cold storage condition well before time of administration and allow to attain room temperature. Do not heat.

2. Shake vial thoroughly to ensure a homogeneous suspension.

3. Using a sterile disposable syringe, withdraw 0.5 mL of suspension.

4. Carefully express the air from the syringe with the needle held upwards to minimize loss of contents.

5. Slowly inject the suspension deep subcutaneously.

6. Do not inject into a blood vessel.

Availability And Storage: 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.

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. Store at 5°C.

POLLINEX®-R Bencard Modified Ragweed Tyrosine Adsorbate Vaccine

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