VISANNE

VISANNE is the brand name for dienogest oral tablets.

VISANNE is available as a 2 mg oral tablet.

VISANNE is indicated in the long-term treatment of endometriosis in adolescents from 12 years of age onward and adults.

VISANNE belongs to the class of medications called progestins
Progestins reduce the effects of estrogen on tissues such as the endometrium (lining of the uterus) and the breast. By reducing the growth effect of estrogen on the endometrium, dienogest helps to reduce the pelvic pain experienced by women with endometriosis.

VISANNE should start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). The dosage of VISANNE is one tablet daily without any break, taken preferably at
the same time each day with some liquid as needed. Tablets must be taken throughout 28 days without regard for bleeding. When a pack is finished the next one should be started without interruption

VISANNE is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• History of or active venous thromboembolic disorder.
  Arterial and cardiovascular diseases, past or present (e.g. myocardial infarction, cerebrovascular events,
  ischaemic heart disease)
• Diabetes mellitus with vascular involvement
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
  Presence or history of liver tumours (benign or malignant)
• Known or suspected sex hormone-dependent malignancies
• Undiagnosed vaginal bleeding
• Hypersensitivity to the active substance or to any of the excipients

Common side effects of VISANNE:

• Weight change
• Increased appetite
• Depressed mood
• Sleep disorder
• Nervousness
• Loss of libido
• Mood altered
• Anxiety
• Depression
• Mood swings
• Headache
• Migraine
• Dry eyes
• Palpitations
• Hypotension
• Shortness of breath
• Nausea
• Abdominal pain
• Flatulence
• Abdominal distention
• Vomiting

Serious side effects are rare with VISANNE.

The following medications may interact with VISANNE:

• Progestogens, including VISANNE, are metabolised mainly by the cytochrome P450 system (CYP3A4) Therefore, inducers or inhibitors of CYP3A4 may affect the drug metabolism of VISANNE
• An increased clearance of sex hormones due to enzyme induction may reduce the therapeutic effect of
• VISANNE and may result in undesirable effects e.g. change in bleeding profile
• A reduced clearance of sex hormones due to enzyme inhibition may increase the therapeutic effects of VISANNE and may result in undesirable effects
• Substances increasing the clearance of sex hormones (diminished efficacy by enzyme-induction), e.g.: phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly oxcarbazepine, topiramate felbamate, griseofulvin and products containing St. John’s wort
• Enzyme induction can already be observed after a few days of treatment. Maximum enzyme induction is generally seen within a few weeks. After the cessation of drug therapy enzyme induction may be sustained for about 4 weeks
• Substances with variable effects on the clearance of sex hormones, e.g.: When co-administered with sex hormones, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of the progestin. These changes may be clinically relevant in some cases.
• Substances decreasing the clearance of progestins (enzyme inhibitors) Dienogest is a substrate of cytochrome
• Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. itraconazole, voriconazole fluconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the progestins.

Bayer Healthcare

There are limited data from the use of VISANNE in pregnant women. Animal studies and data from women exposed to VISANNE during pregnancy reveal no special risks on pregnancy, embryonic/ foetal development, birth or development after birth for humans. However, VISANNE should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.

• dienogest