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This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or
enclosures. |
PUBLIC ADVISORY
Health Canada Endorsed Important Safety Information on
RITONAVIR and FLUTICASONE PROPIONATE |
Subject : Information for patients regarding a drug interaction
between ritonavir (NORVIR®/KALETRA®) and
fluticasone propionate (FLONASE®, FLOVENT®,
ADVAIR®)
MISSISSAUGA, Ontario (January 27, 2004) – GlaxoSmithKline
Inc. is informing patients of the results of a drug interaction study
conducted with FLONASE® (fluticasone propionate) aqueous
nasal spray and NORVIR® (ritonavir, Abbott Laboratories).
A recent clinical study in healthy volunteers found that concurrent administration
of NORVIR® (ritonavir, Abbott Laboratories) and FLONASE®
(fluticasone propionate, GlaxoSmithKline) aqueous nasal spray, an intranasal
corticosteroid for allergies, resulted in greatly increased concentrations
of fluticasone propionate in the blood. In addition, GlaxoSmithKline has
received reports of adrenal suppression in patients who were taking ritonavir
and fluticasone propionate simultaneously. Adrenal suppression is a condition
in which the adrenal glands produce too little of the hormones required
for the body’s normal functioning, reducing the body’s ability
to heal, particularly after surgery, infection or serious injury. Therefore,
ritonavir and fluticasone should only be taken together if the benefit
to the patient outweighs the risk of adrenal suppression. Care should
also be taken for patients who are taking other drugs that are known to
affect fluticasone propionate metabolism, such as azole antifungals.
Ritonavir, a protease inhibitor used in the treatment of HIV/AIDS, is
a potent inhibitor of the enzymes responsible for elimination of fluticasone
propionate from the body. When taken together with some inhaled or intranasal
corticosteroids, patients may be at risk of corticosteroid side effects,
such as adrenal suppression. Inhaled or intranasal corticosteroids are
used to treat allergies, asthma, and/or chronic obstructive pulmonary
disease (COPD).
Other corticosteroid preparations are known to share the same elimination
pathway as fluticasone propionate and could potentially be affected by
the interaction with ritonavir, resulting in adverse events similar to
that seen with fluticasone propionate. HIV-infected patients who
are also taking a corticosteroid preparation should contact their physician
to discuss their current medications.
Patients are advised that medications should not be stopped without
consulting a physician. Abruptly stopping medications may result in deteriorating
health, which may be life-threatening.
Fluticasone propionate is also contained in the products FLOVENT®
(fluticasone propionate) inhalation aerosol and dry powder for inhalation,
and ADVAIR® (salmeterol xinafoate/fluticasone propionate)
inhalation aerosol and dry powder for inhalation, manufactured by GlaxoSmithKline.
GlaxoSmithKline has sent a letter to health care professionals in Canada
informing them of the drug interaction between ritonavir and FLONASE®
and of other potential interactions with inhaled or intranasal corticosteroids
by the same pathway as fluticasone. This information may be obtained
on the Canadian website of GlaxoSmithKline ( http://www.gsk.ca/en/)
or on the website of the Therapeutic Products Directorate of Health Canada
(http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2004/index_e.html
).
Suspected adverse reactions arising from the simultaneous use of ritonavir
and fluticasone propionate can be reported directly to GlaxoSmithKline
at the following address:
| GlaxoSmithKline Inc.
7333 Mississauga Road N
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals
may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
For other inquiries: please refer to contact information
The AR
Reporting Form and the AR
Guidelines can be found on the Health Canada web site or in
The Canadian Compendium of Pharmaceuticals and Specialties. |
NORVIR® and KALETRA® are registered trademarks,
used under license by Abbott Laboratories.
FLONASE®, FLOVENT® and ADVAIR®
are registered trademarks, used under license by GlaxoSmithKline Inc.
|
