SAVELLA Film-coated tablet (2017)

Βιβλιογραφική αναφορά

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Allergan, Inc.

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BOXED WARNING SECTION

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other ...

1. Indications and Usage

Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

2. Dosage and Administration

Savella is given orally with or without food. Taking Savella with food may improve the tolerability of the drug. 2.1 Recommended Dosing The recommended dose of Savella is 100 mg/day (50 mg twice daily). ...

3. Dosage Forms and Strengths

Film-coated, immediate-release tablets in four strengths: 12.5 mg, 25 mg, 50 mg, and 100 mg of milnacipran hydrochloride. 12.5 mg tablets are round, blue, F on one side, L on the reverse; 25 mg tablets ...

4. Contraindications

4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Savella or within 5 days of stopping treatment with Savella is contraindicated because of an increased ...

5. Warnings and Precautions

5.1 Suicide Risk Savella is a selective serotonin and norepinephrine re-uptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Patients, both ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following additional adverse reactions have been identified from spontaneous reports of Savella received worldwide. These adverse reactions have been chosen for inclusion because of a combination of ...

7. Drug Interactions

Milnacipran undergoes minimal CYP450 related metabolism, with the majority of the dose excreted unchanged in urine (55%) and has a low binding to plasma proteins (13%). In vitro and in vivo ...

8.1. Pregnancy

Pregnancy Category C. Risk Summary There are no adequate or well-controlled studies in pregnant women. Neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine (such as Savella), or ...

8.3. Nursing Mothers

Milnacipran is present in the milk of lactating women treated with Savella. In a pharmacokinetic study, a single, oral dose of 50 mg milnacipran HCl tablet was administered to 8 lactating women who were ...

8.4. Pediatric Use

Safety and effectiveness of Savella in a fibromyalgia pediatric population below the age of 18 have not been established [see Boxed Warning, Indications and Usage (1), and Warnings and Precautions ...

8.5. Geriatric Use

In controlled clinical studies of Savella, 402 patients were 60 years or older, and no overall differences in safety and efficacy were observed between these patients and younger patients. In view of the ...

9.1. Controlled Substance

Milnacipran is not a controlled substance.

9.2. Abuse

Milnacipran did not produce behavioral signs indicative of abuse potential in animal or human studies.

9.3. Dependence

Milnacipran produces physical dependence, as evidenced by the emergence of withdrawal symptoms following drug discontinuation, similar to other SNRIs and SSRIs. These withdrawal symptoms can be severe. ...

10. Overdosage

There is limited clinical experience with Savella overdose in humans. In clinical trials, cases of acute ingestions up to 1000 mg, alone or in combination with other drugs, were reported with none being ...

11. Description

Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical ...

12.1. Mechanism of Action

The exact mechanism of the central pain inhibitory action of milnacipran and its ability to improve the symptoms of fibromyalgia in humans are unknown. Preclinical studies have shown that milnacipran is ...

12.2. Pharmacodynamics

Cardiovascular Electrophysiology The effect of Savella on the QTcF interval was measured in a double-blind placebo- and positive-controlled parallel study in 88 healthy subjects using 600 mg/day Savella ...

12.3. Pharmacokinetics

Milnacipran is well absorbed after oral administration with an absolute bioavailability of approximately 85% to 90%. The exposure to milnacipran increased proportionally within the therapeutic dose range. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Dietary administration of milnacipran to rats at doses of 50 mg/kg/day (2 times the MRHD on a mg/m2 basis) for 2 years caused a statistically significant increase in the incidence ...

13.2. Animal Toxicology and/or Pharmacology

Hepatic Effects Chronic administration (2 years) of milnacipran to rats at 15 mg/kg (0.6 times the MRHD on an mg/m2 basis) and higher doses showed increased incidences of centrilobular vacuolation ...

14. Clinical Studies

Management of Fibromyalgia The efficacy of Savella for the management of fibromyalgia was established in two double-blind, placebo-controlled, multicenter studies in adult patients (18-74 years of age). ...

16.1. How Supplied

12.5-mg tablets: Blue, round, film-coated tablets, debossed with F on one side and L on the reverse Bottles of 60: NDC 0456-1512-60 10 X 10 Unit Dose: NDC 0456-1512-63 25-mg tablets: White, ...

16.2. Storage and Handling

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

17. Patient Counseling Information

Information for Patients Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Savella and should ...