DinoSen 2

Indications

Dinosen is prescribed for managing endometriosis. As a member of the progestin medication class, Dinosen effectively mitigates estrogen’s impact on tissues such as the endometrium (uterine lining) and breast. By diminishing estrogen’s stimulating effects on the endometrium, Dinosen helps alleviate the pelvic pain associated with endometriosis.
Use this medication only under the supervision of a registered healthcare professional.

Pharmacology

Dienogest functions as a progesterone receptor (PR) agonist with a comparable but weak affinity to progesterone, yet it exhibits a potent progestational effect on the endometrium, leading to endometrial atrophy with prolonged use. It offers antiproliferative, immunological, and antiangiogenic benefits to endometrial tissue. By lowering endogenous estradiol levels, dienogest suppresses the trophic effects of estradiol on both eutopic and ectopic endometrial tissue. Continuous use creates a hyperprogestogenic and moderately hypoestrogenic hormonal environment, prompting initial decidualization of endometrial tissue. Additionally, it acts as an antagonist at androgen receptors, alleviating symptoms like acne and hirsutism.

Dosage & Administration

Dinosen can be initiated on any day of the menstrual cycle. The recommended dosage is 2 mg daily, taken consistently at the same time each day, with liquid as necessary. It should be taken continuously without considering vaginal bleeding. Upon finishing one pack, the next should be started immediately.

If a dose is missed, take 2 mg as soon as remembered, then resume the regular schedule. If vomiting or diarrhea occurs, replace the lost dose with 2 mg.
Use this medication only under the supervision of a registered healthcare professional.

Interaction

Progestins like Dinosen are primarily metabolized by the cytochrome P450 3A4 system. Consequently, CYP3A4 inducers or inhibitors can influence progestin metabolism. Known inhibitors, such as azole antifungals (e.g., ketoconazole, itraconazole), cimetidine, and certain macrolides (e.g., erythromycin, clarithromycin), may elevate progestin levels and lead to adverse effects.

Contraindications

Dinosen is contraindicated for individuals with hypersensitivity to dienogest or any components of the formulation. It should not be used in cases of active venous thromboembolic disorders, cardiovascular diseases (e.g., myocardial infarction, stroke), diabetes with vascular complications, severe hepatic disease (until liver function normalizes), known or suspected hormone-dependent malignancies, or undiagnosed vaginal bleeding.

Side Effects

Side effects are more common during the initial months of Dinosen treatment but typically diminish over time. Commonly reported effects include headache (9%), breast tenderness (5.4%), mood changes (5.1%), and acne (5.1%).

• Nervous System: Headache, migraine.
• Cardiovascular: Rare circulatory issues, palpitations.
• Vascular: Rare hypotension.
• Gastrointestinal: Common nausea, abdominal pain, flatulence.
• Metabolic: Weight gain (3.6%).
• Psychiatric: Mood changes, irritability, nervousness.

Pregnancy & Lactation

Data on the use of Dienogest during pregnancy is limited. While animal studies reveal no significant risks to pregnancy or fetal development, Dienogest should not be administered to pregnant women, as treatment for endometriosis is unnecessary during this time.

During lactation, Dienogest is not recommended due to its presence in breast milk. A decision should be made whether to discontinue breastfeeding or abstain from therapy, considering the benefits for both mother and child.

Precautions & Warnings

Prior to starting Dinosen, confirm the absence of pregnancy. Non-hormonal contraception (e.g., barrier methods) is advised if needed.

As a progestin-only treatment, Dinosen carries the same warnings and precautions as other progestin therapies:

• Menstrual Changes: Dinosen may alter menstrual bleeding patterns in most women.
• Liver Issues: Contraindicated in patients with severe hepatic disease.
• Fertility: Ovulation is often inhibited, but Dinosen is not a contraceptive; non-hormonal methods should be employed if contraception is desired.

Use in Special Populations

• Children: Not indicated for pre-menarche children; safety in adolescents (menarche to 18 years) is not established.
• Elderly: No relevant indications for the geriatric population.

Overdose Effects

Acute toxicity studies show no significant adverse effects from unintentional ingestion of doses exceeding the daily therapeutic range. There is no specific antidote, and doses of 20-30 mg/day (10-15 times higher than prescribed) have been well tolerated over 24 weeks.

Therapeutic Class

Female sex hormones

Storage Conditions

Store below 30°C, protected from light and moisture. Keep out of reach of children.