SAVELLA Rx

Indications for SAVELLA:

Fibromyalgia.

Adult:

May take with food. Titrate dose. Day 1: 12.5mg once. Days 2–3: 12.5mg twice daily. Days 4–7: 25mg twice daily. After Day 7: 50mg twice daily (recommended dose); max 100mg twice daily. Severe renal impairment (CrCl 5–29mL/min): maintenance 25mg twice daily; max 50mg twice daily. Withdraw gradually.

Children:

<18yrs: not recommended.

Contraindications:

Concomitant MAOIs during or within 5 days of discontinuing milnacipran. During or within 14 days of discontinuing an MAOI. Concomitant linezolid or IV methylene blue. Uncontrolled narrow-angle glaucoma.

Boxed Warning:

Suicidality and antidepressant drugs.

Warnings/Precautions:

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor closely for clinical worsening or unusual changes in all patients. Monitor for serotonin syndrome; discontinue if occurs. Substantial alcohol abuse, chronic liver disease, end stage renal disease: not recommended. Hypertension. Heart disease. Arrhythmias. Monitor BP and HR prior to starting therapy and periodically thereafter; reduce dose or discontinue if elevation is sustained. Seizure disorder. Mania. Severe hepatic dysfunction. Discontinue if jaundice or liver dysfunction occurs. Moderate renal impairment. Volume depleted. Hyponatremia risk (esp. in elderly). History of dysuria. GU obstruction. Risk of bleeding. Controlled narrow-angle glaucoma. Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Pregnancy (Cat.C; see full labeling for effects on fetus). Nursing mothers.

Pharmacological Class:

SNRI.

Interactions:

See Contraindications. Avoid IV digoxin (postural hypotension, tachycardia). Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Increased risk of bleeding with concomitant aspirin, NSAIDs, or others that affect coagulation. May antagonize certain antihypertensives (eg, clonidine). Caution with other CNS-active drugs. Arrhythmias, hypertension with epinephrine, norepinephrine.

Adverse Reactions:

Nausea, vomiting, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, palpitations, increased heart rate, dry mouth, hypertension; rare: GU effects in men.

How Supplied:

Tabs—60; Titration Pack (4 week supply)—1