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Safety Profile for RECTIV

In the clinical study of RECTIV, the most common adverse events (AEs) observed for RECTIV and placebo were:

All patients were instructed to take 650 mg of acetaminophen prior to each administration of study medication for headache prophylaxis²
Headache was not treatment-limiting in most nitroglycerin-treated patients²

Other reasons for discontinuation were: AE, protocol violation, lost to follow-up, and voluntary withdrawal.²

Seven out of 123 patients (5.7%) in the RECTIV group, and 1 out of 124 patients (0.8%) in the placebo group discontinued treatment due to headache²
RECTIV produces dose-related headaches, which may be severe. Tolerance to headache occurs¹
Headaches may recur after each dose; they are typically short in duration, can be treated with an over-the-counter analgesic, and are reversible upon discontinuation of treatment¹

Please see Contraindications and Warnings and Precautions below.

References: 1. RECTIV [package insert]. Bridgewater, NJ: Aptalis Pharma US, Inc.; July 2013. 2. Berry SM, Barish CF, Bhandari R, et al. Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2013;13(1):106.

IMPORTANT SAFETY INFORMATION

Contraindications

Use of phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil, vardenafil, and tadalafil), as these are shown to potentiate the hypotensive effects of organic nitrates.
Severe anemia
Increased intracranial pressure
Known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment.

Warnings and Precautions

Cardiovascular Disorders: Venous and arterial dilatation as a consequence of nitroglycerin treatment can result in hypotension. Exercise caution in patients with any of the following conditions: blood volume depletion, existing hypotension, cardiomyopathies, congestive heart failure, acute myocardial infarction, or poor cardiac function for other reasons. If patients with any of these conditions are treated with RECTIV, monitor cardiovascular status and clinical condition. The adverse reactions of RECTIV are likely to be more pronounced in the elderly.
Headache: RECTIV produces dose-related headaches, which may be severe. Tolerance to headaches occurs.

Drug Interactions

The following drug interactions may occur in patients taking RECTIV:

PDE5 inhibitors: potentiation of hypotensive effects of organic nitrates; concomitant use is contraindicated
Antihypertensives: possible additive hypotensive effects
Aspirin: increased nitroglycerin levels
Tissue-type Plasminogen Activator (t-PA): decreased thrombolytic effect
Heparin: anticoagulant effect of heparin may be reduced. Monitor activated partial thromboplastin time (APTT).
Ergotamine: increased bioavailability of ergotamine
Alcohol: additive vasodilatory effects to nitroglycerin. Consumption of alcohol should be avoided.

Adverse Reactions

The most common adverse reactions in RECTIV-treated patients (incidence ≥2% and greater than placebo) were headache (64% vs 41%) and dizziness (5% vs 0%).

Indications and Usage

RECTIV^® (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.

Please see full Prescribing Information.

The information provided in this site is intended for U.S. healthcare professionals only. The products described on this site may have different product labeling in countries outside of the United States. For additional information about RECTIV, call Allergan Medical Information toll-free at 1.800.678.1605.

Allergan^® and its design are trademarks of Allergan, Inc.

RECTIV^® is a registered trademark of Aptalis Pharma US, Inc., an Allergan affiliate.