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ADDYI is a brand name for Flibanserin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .......................................................................................... 4 1.1 Pediatrics ..............................................................................................................................4 1.2 Geriatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • It is recommended to use the ADDYI Prescriber Checklist and ADDYI Pharmacist’s Checklist before prescribing and dispensing ADDYI. ca. • Before prescribing ADDYI collect medical history and concomitant medications use from all patients.
• ADDYI is contraindicated for use in patients with any degree of hepatic impairment. See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and DRUG INTERACTIONS sections. Product Monograph ADDYI (flibanserin) Page 6 of 44 • CYP2C19 poor metabolizers had increased flibanserin exposures compared to CYP2C19 extensive metabolizers (see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY).
, hypotension and syncope) in patients who are CYP2C19 poor metabolizers (see WARNINGS AND PRECAUTIONS/Endocrine and Metabolism/Genetic Polymorphism). • Moderate or strong inhibitors of CYP3A4 cause a significant increase in exposure to flibanserin when co-administered with ADDYI and are therefore contraindicated (see CONTRAINDICATIONS, and DRUG INTERACTIONS).
• Counsel patients on the safe use of ADDYI (see WARNINGS AND PRECAUTIONS). 2 Recommended Dose and Dosage Adjustment • The recommended dosage of ADDYI is 100 mg, taken orally once daily at bedtime. Discontinue treatment after 8 weeks if the patient does not report an improvement in sexual desire and/or a reduction in associated distress.
• Counsel patients to not exceed the recommended dose. 3 Administration • ADDYI is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, and CNS depression (such as somnolence and sedation).
Use of ADDYI Before or After Moderate or Strong CYP3A4 Inhibitor Use • If initiating ADDYI following moderate or strong CYP3A4 inhibitor use, start ADDYI 2 weeks after the last dose of the CYP3A4 inhibitor. • If initiating a moderate or strong CYP3A4 inhibitor following ADDYI use, start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of ADDYI.
• In cases where the benefit of initiating a moderate or strong CYP3A4 inhibitor within 2 days of stopping ADDYI clearly outweighs the risk of flibanserin exposure related severe hypotension and syncope, carefully monitor the patient for signs of hypotension and syncope.
5 Missed Dose If a dose of ADDYI is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose.
1 Adverse Reaction Overview In clinical trials of women with HSDD, patients were treated with ADDYI 100 mg as a single dose before bedtime. 0%). The majority of these adverse reactions were of mild to moderate intensity and emerged during the first 14 days of treatment.
5%). The majority of these adverse reactions were of mild to moderate intensity and emerged during the first 4 weeks of treatment. 9% in placebo-treated patients (n=1905). 9%). 5% of placebo-treated patients. 2% in placebo-treated patients (n=849).
2%). 8% of placebo-treated patients. Reports of serious adverse events in postmenopausal women, regardless of causality, are listed below. 1%). • Cardiac disorders: myocardial infarction • Gastrointestinal disorders: pancreatitis, duodenitis, haematemesis, upper gastrointestinal haemorrhage • Infections and infestations: dengue fever, gastroenteritis viral • Injury, poisoning and procedural complications: alcohol poisoning, meniscus lesion, road traffic accident, tibia fracture • Investigations: hepatic enzyme increased, liver test abnormal • Neoplasms benign, malignant and unspecified (incl cysts and polyps): breast cancer in situ, chronic lymphocytic leukaemia • Nervous system disorders: intraventricular haemorrhage Adverse reactions of syncope and hypotension are more common in patients who have elevated exposure to flibanserin due to concomitant use of moderate or strong CYP3A4 inhibitors (see DRUG INTERACTIONS; CONTRAINDICATIONS).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The 100 mg ADDYI dosage at bedtime was administered to 3,641 women with acquired, generalized HSDD in clinical trials.
Please see SERIOUS WARNINGS AND PRECAUTIONS BOX. Carcinogenesis and Mutagenesis Statistically significant increases in combined mammary tumours (adenoacanthomas and adenocarcinomas) were observed in female mice administered flibanserin at doses of 200 and 1200 mg/kg/day (approximately 3 and 10 times the clinical exposures) (see NON-CLINICAL TOXICOLOGY/Carcinogenesis).
The clinical significance of these findings is unknown.
Cardiovascular Hypotension and Syncope:
The use of ADDYI can cause hypotension and syncope. 1% of placebo-treated patients. The risk of hypotension and syncope is increased if ADDYI is taken during waking hours or if higher than the recommended dose is taken. ADDYI should be used with caution in patients with pre-existing conditions that predispose to hypotension.
Patients who experience pre-syncope should immediately lie supine and promptly seek medical help if the symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope.
Heart Rate:
A double-blind study in 56 men and women conducted to assess the changes to the electrocardiogram in healthy individuals found mildly increased heart rates and an increased incidence in palpitations (3 vs. 0) after a supra-therapeutic dose of 100 mg tid flibanserin vs.
placebo (see CLINICAL PHARMACOLOGY). In Phase 3 trials, tachycardia and palpitations were reported more frequently in patients taking ADDYI than placebo. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 100 mg croscarmellose sodium, hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.
Product Monograph ADDYI (flibanserin) Page 8 of 44 Effects on heart rate were also noted in a study evaluating the interaction of ADDYI with alcohol, where alcohol intake corresponded to a dose-dependent increase in heart rate (see WARNINGS AND PRECAUTIONS/ Neurologic/Use with alcohol).
ADDYI is contraindicated in: • Patients with known hypersensitivity to flibanserin or any component of the ADDYI tablet formulation. For a complete listing, see the DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
Product Monograph ADDYI (flibanserin) Page 5 of 44 • Patients taking a moderate or strong CYP3A4 inhibitor due to the risk of significantly increased flibanserin plasma concentrations which may result in severe hypotension and syncope.
• Patients with hepatic impairment, due to the risk of significantly increased flibanserin plasma concentrations which may result in severe hypotension and syncope. • Patients who are pregnant or breastfeeding. • Patients whose resting systolic blood pressure is less than 110 mmHg or diastolic blood pressure less than 60 mmHg and who are using alcohol as this was not studied.
5-fold, compared to digoxin alone (see Drug-Drug Interactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Of the 2,798 premenopausal patients, 2,141 received treatment for at least 6 months, 1,327 received treatment for at least 12 months, and 603 received treatment for at least 18 months. Of the 843 postmenopausal patients, 506 received treatment for at least 6 months.
Adverse reactions that occurred in at least 1% of women treated with ADDYI 100mg qhs in double-blind, placebo-controlled pivotal clinical trials are presented in Table 2. 1 Clinical Trial Adverse Reactions – Pediatrics Not […]
5 oz spirits-type drinks for a 70 kg person. ADDYI should be used with caution in patients with pre-existing cardiac conditions. , somnolence, sedation). Patients should not drive or engage in other activities requiring full alertness after taking ADDYI until they know how ADDYI affects them.
Endocrine and Metabolism Genetic polymorphism:
CYP2C19 poor metabolizers had increased flibanserin exposures compared to CYP2C19 extensive metabolizers. In a study with 9 subjects who were poor CYP2C19 metabolizers, syncope occurred in one subject (see DRUG INTERACTIONS; CLINICAL PHARMACOLOGY).
) in patients who are CYP2C19 poor metabolizers. The frequencies of poor CYP2C19 metabolizers are approximately 2-5% among Caucasians and Africans and approximately 2–15% among Asians. , ketoconazole, itraconazole, fluconazole, ritonavir, or clarithromycin) is contraindicated (see CONTRAINDICATIONS).
See DOSAGE AND ADMINISTRATION section for dosing considerations in cases where a patient needs to use a moderate or strong CYP3A4 inhibitor and is using, or is planning to use, ADDYI.
Weak CYP3A4 inhibitors:
Concomitant use of multiple weak CYP3A4 inhibitors (including certain herbal supplements and non-prescription drugs) could also lead to clinically relevant increases in flibanserin concentrations which may increase the risk of hypotension and syncope (see DRUG INTERACTIONS).
5-fold in patients with mild hepatic impairment and t½ was longer (26 hours compared to 10 hours in matching healthy controls), compared to those with normal hepatic function (see CLINICAL PHARMACOLOGY). The use of ADDYI in patients with any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to severe hypotension and syncope.
Therefore, the use of ADDYI is contraindicated in patients with hepatic impairment (see CONTRAINDICATIONS).
Immune Anaphylactic/ Hypersensitivity reactions:
Rare anaphylactic reactions have been reported. Symptoms included difficulty breathing or rash. Supportive treatment should address the symptoms. , somnolence, sedation). In eight randomized, placebo-controlled, double-blind trials of women with HSDD, the incidence of somnolence, sedation or fatigue was 18% in patients treated with 100 mg ADDYI once daily at bedtime and 8% in placebo.
The risk of CNS depression may be increased if ADDYI is taken during waking hours, or if ADDYI is taken with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations, such as CYP3A4 inhibitors.
Product Monograph ADDYI (flibanserin) Page 9 of 44 Counsel patients to use ADDYI before bedtime and immediately lie supine if they feel they are about to pass out. Counsel patients not to drive or engage in other activities requiring full alertness after taking ADDYI until they know how ADDYI affects them.
, somnolence) compared to the use of ADDYI alone. ) Use with Alcohol: Taking ADDYI within two hours after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after […]