Rectiv (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal carcinogenicity studies with topically applied nitroglycerin have not been performed.

Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At the highest dose, the incidence of hepatocellular carcinomas was 52% compared to 0% in untreated controls. Incidence of testicular tumors were 52% vs. 8% in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.

Nitroglycerin was mutagenic in the in vitro bacterial reverse mutation (Ames) assay with Salmonella typhimurium. A similar mutation in this S. typhimurium was also reported with other NO donors. There was no evidence of clastogenic potential in multiple assays including a rodent dominant lethal assay, an in vitro Chinese Hamster Ovary assay that was conducted in the absence of metabolic activation, and several in vivo chromosomal aberration assays conducted in rats and dogs.

In a three-generation reproduction study, rats received dietary nitroglycerin at doses up to approximately 434 mg/kg/day for 6 months prior to mating of the F0 generation with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males.

14 CLINICAL STUDIES

RECTIV ointment was evaluated in a 3-week double-blind, randomized, multi-center, placebo-controlled study. Patients with a painful chronic anal fissure for at least 6 weeks and moderate or severe pain prior to treatment (≥ 50 mm on the 100mm visual analog scale, VAS) were randomized to receive 0.4% (1.5mg) nitroglycerin or placebo ointment applied to the anal canal every 12 hours. Pain as assessed by the change in VAS from baseline to Days 14-18 was lower in patients receiving 0.4% ointment compared to placebo. The mean change from baseline was 44mm for RECTIV and 37mm for placebo. The difference in the mean change in pain between RECTIV and placebo was -7.0mm (95% Confidence Interval: -13.6 to -0.4mm).

16 HOW SUPPLIED/STORAGE AND HANDLING

RECTIV (nitroglycerin) Ointment 0.4% is available in 30 g (NDC 58914-301-80) aluminum tubes with polyethylene screw caps.

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Keep the tube tightly closed. Use within 8 weeks of first opening.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)

17.1 Interaction with PDE5 inhibitors

Advise patient not to use RECTIV with medications for erectile dysfunction such as Viagra (sildenafil), Levitra (vardenafil), and Cialis (tadalafil). These products have been shown to increase the hypotensive effects of RECTIV and other nitrate drugs.

17.2 Hypotension

Advise patients that treatment with RECTIV may be associated with light-headedness on standing, especially just after rising from a lying or seated position. The effect may be more frequent in patients who have also consumed alcohol, since alcohol use contributes to hypotension. Advise patients to stand up from the supine or sitting position slowly.

17.3 Headaches

Advise patients that headaches sometimes accompany treatment with RECTIV. For patients who get these headaches, the headaches may indicate the activity of the drug. Tolerance to headaches develops. Advise patients that if they experience headache they should not alter the schedule of their RECTIV treatment to avoid the occurrence of headache. An analgesic, such as acetaminophen, may be used to prevent or relieve the headaches.

17.4 Dizziness

Advise patients that dizziness has been reported as a side-effect of treatment with RECTIV.

Advise patients not to drive or operate machinery immediately after applying RECTIV.

17.5 FDA-Approved Patient Labeling

Patient Information

RECTIV ® [REC-tiv] (Nitroglycerin) Ointment 0.4%

IMPORTANT: For intra-anal use only

Read the Patient Information that comes with RECTIV before you start using the product and each time you get a refill because there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions about RECTIV, ask your healthcare provider.

What is RECTIV?

RECTIV is a prescription medicine used to treat moderate to severe pain caused by chronic anal fissures. An anal fissure is a tear in the skin lining the anal canal.

RECTIV is not suitable for children and adolescents under the age of 18 years because it has not been assessed in people in this age group.

Who should not use RECTIV?

Do not use RECTIV if you:

  • are taking a medicine for erectile dysfunction (male impotence), for example Viagra (sildenafil), Cialis (tadalafil) or Levitra (vardenafil).
  • have been told by your doctor that you have severe anemia (low numbers of red blood cells in your blood)
  • have increased intracranial pressure or high pressure within your skull e.g. following head trauma or bleeding in your brain
  • are allergic to any of the ingredients in RECTIV or if you have had allergic reactions to similar medicines in the past. See the end of this leaflet for a list of ingredients in RECTIV.

What should I tell my healthcare provider before using RECTIV?

Tell your healthcare provider about all your medical conditions, including if you:

  • have low blood pressure
  • have recently had a heart attack
  • have heart or blood vessel disorders
  • suffer from migraine or recurrent headaches
  • are pregnant or plan to become pregnant. It is not known if RECTIV will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if the components of RECTIV will harm your child if you breast-feed.

RECTIV may lower your blood pressure. When getting up from a lying or sitting position, you should get up slowly, otherwise you might feel faint.

Tell your healthcare provider about all the medicines you take , including prescription and non-prescription medicines, vitamins and herbal supplements. Other medicines may affect how RECTIV works. RECTIV may also affect how other medicines work.

Specifically, tell your doctor if you are taking any of the following:

  • other nitroglycerin containing products
  • a medicine for erectile dysfunction (male impotence), for example sildenafil, tadalafil or vardenafil (see the section above ‘Who should not use RECTIV’)
  • medicines used to treat high blood pressure
  • are taking aspirin, ergotamine (used to treat migraine) or are receiving tissue-type plasminogen activator (used to help dissolve blood clots formed in blood vessels in the heart, lungs and brain)
  • are to be given heparin. If so, close monitoring of your blood will be required as your dose of heparin may need to be altered. Please discuss with your doctor before stopping RECTIV.

How should RECTIV be used?

Use RECTIV exactly as prescribed. See detailed Patient Instructions for Applying RECTIV at the end of this Patient Information leaflet.

Treatment may be continued for up to 3 weeks. If your anal pain does not get better after using RECTIV you should talk to your doctor.

What should I avoid while using RECTIV?

Do not drive or operate machinery immediately after applying RECTIV. If you feel dizzy or light-headed after applying the ointment do not drive or operate machinery until the dizziness has stopped.

Avoid consuming alcohol while you are being treated with RECTIV as your blood pressure is more likely to be affected if you consume alcoholic beverages.

What are the possible side effects of RECTIV?

RECTIV can cause serious side-effects: Stop using the ointment and seek medical attention immediately if you have an allergic reaction. You may have swelling of the face, lips, tongue or throat, or difficulty breathing.

Common side-effects of RECTIV are:

  • Headaches, which can be severe. You could take painkillers for this (such as acetaminophen). If the headaches are unpleasant, you may need to ask your doctor whether you should stop using RECTIV.
  • Dizziness, faintness on standing, or light-headedness

These are not all the possible side effects of RECTIV. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store RECTIV?

  • Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
  • Keep the tube tightly closed.
  • Use within 8 weeks of first opening.

Keep RECTIV out of the reach of children.

Do not use RECTIV after the expiry date which is stated on the label and carton after ‘EXP.’ The expiry date refers to the last day of that month.

General information about RECTIV

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use RECTIV for a condition for which it is not prescribed. Do not give RECTIV to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about RECTIV. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about RECTIV that is written for health professionals.

For more information call 1-800-678-1605 or visit www.RECTIV.com.

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