Generic Savella ( Milnacipran )

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Savella is a serotonin and norepinephrine reuptake inhibitor (SNRI) used to manage fibromyalgia in adults. It helps reduce pain and fatigue, though it does not cure the condition. The medication works by balancing two chemical messengers in the brain and spinal cord that are involved in how you perceive pain.
A note on availability: Savella is not approved by Health Canada and is not marketed in this country. The brand was never submitted for review, so there is no Canadian DIN for it. Some Canadian pharmacies can source milnacipran through international channels, which is how we are able to offer it here. The dosing and safety information below comes from the U.S. prescribing information, which reflects how the drug is used in the market where it is approved.
The usual starting dose is 12.5 mg once on day one. From days two to three, it is 12.5 mg twice daily. From days four to seven, it is 25 mg twice daily. After that, the target is 50 mg twice daily. The maximum daily dose is 200 mg, though many people do well on less.
The administration form is film-coated tablets in 12.5 mg, 25 mg, 50 mg, and 100 mg strengths.
The medication does not work overnight. Some people notice a difference in pain within the first week or two, but the full benefit for fibromyalgia usually takes four to six weeks of steady dosing.
Alcohol should be avoided during treatment. Drinking heavily while taking milnacipran can increase the risk of liver damage and add to dizziness and drowsiness.
The most common side effects are nausea, headache, constipation, and dizziness.
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Common Use Savella

Milnacipran is an SNRI, which means it blocks the reuptake of serotonin and norepinephrine at nerve endings. By keeping more of these neurotransmitters available in the space between nerve cells, it changes how the central nervous system processes pain signals. Fibromyalgia is thought to involve a kind of over-amplification of pain in the brain and spinal cord, and milnacipran appears to dial that down. It is approved by the U.S. Food and Drug Administration for the management of fibromyalgia in adults. It is also used in some countries for major depressive disorder, but that is not its approved use in the United States. Health Canada has not approved milnacipran for any indication. The related drug levomilnacipran (Fetzima) is approved in Canada for depression, but it is a different molecule and is not interchangeable with milnacipran. Milnacipran is not approved for use in children or adolescents under 18 years of age.

Basic Savella Information

• INN (International Nonproprietary Name): Milnacipran hydrochloride
• Brand names available in Canada: Savella® is not marketed in Canada. Milnacipran is sold in other countries under brand names including Ixel®, Dalcipran®, and Toledomin®. Levomilnacipran (Fetzima®) is a different drug and is available in Canada.
• ATC Code: N06AX17
• Forms and dosages: Film-coated tablets – 12.5 mg, 25 mg, 50 mg, and 100 mg. A titration pack containing 12.5 mg and 25 mg tablets is also available in some markets.
• Manufacturers in Canada: Not applicable. Savella is manufactured by Allergan (now part of AbbVie) for the U.S. market. Milnacipran is also produced by Pierre Fabre Médicament for other markets under the Ixel brand. No Canadian manufacturer holds a DIN for milnacipran.
• Registration status in Canada: Not approved. Health Canada has not issued a Notice of Compliance for milnacipran. There is no DIN for any milnacipran product in the Canadian Drug Product Database. The drug company did not submit data to Health Canada for review, which is why it is not available here through standard distribution.
• OTC / Rx classification: Prescription only (Rx) in countries where it is approved. Not legally sold over-the-counter anywhere.

Dosage & Direction

Savella is taken twice daily, with or without food. The titration schedule is designed to let your body adjust and to reduce the chance of nausea and other side effects. The standard schedule is: day one, 12.5 mg once. Days two and three, 12.5 mg twice daily. Days four through seven, 25 mg twice daily. After day seven, the dose is usually increased to 50 mg twice daily. That is the recommended maintenance dose. Some people need a higher dose, up to 100 mg twice daily (200 mg per day), based on how they respond and how well they tolerate it. Your doctor will decide whether to go up. Take the second dose in the late afternoon or early evening, not too close to bedtime, because milnacipran can be activating for some people and interfere with sleep. Swallow the tablet whole with water. Do not chew or crush it. If you have severe kidney problems, your doctor will adjust the dose downward. The usual adjustment is 25 mg twice daily for severe impairment. Do not stop the medication suddenly. Withdrawal symptoms can occur, including nausea, dizziness, irritability, and trouble sleeping. Your doctor will taper the dose slowly when it is time to stop.

Precautions

Milnacipran can raise blood pressure and heart rate. Your doctor should check your blood pressure before you start and periodically during treatment. If you have uncontrolled hypertension, severe or unstable coronary heart disease, or a recent heart attack, this medication is not for you. Tell your doctor if you have any heart condition or if you take other drugs that increase blood pressure. Seizures have been reported with milnacipran, so it should be used with caution if you have a history of seizure disorder. The medication can cause liver injury. In clinical trials, mild elevations in liver enzymes were more common in people taking milnacipran than in those taking placebo. Rare cases of severe liver injury, including fulminant hepatitis, have been reported. If you develop jaundice (yellowing of the skin or eyes), dark urine, or persistent nausea, stop the medication and see a doctor right away. Do not drink heavily while taking milnacipran, because alcohol increases the risk of liver damage. Milnacipran can cause hyponatremia (low sodium in the blood), especially in older adults and people taking diuretics. Symptoms include headache, difficulty concentrating, memory problems, confusion, and weakness. If these occur, contact your doctor. The medication can increase the risk of bleeding, particularly when taken with NSAIDs, aspirin, or blood thinners. Tell your doctor if you take any of these. Antidepressants, including milnacipran, may increase suicidal thoughts or behaviour in some people, especially young adults, during the first weeks of treatment or after dose changes. If you notice worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Milnacipran is not recommended during pregnancy. It passes into breast milk and breastfeeding is not recommended while taking it. Women who could become pregnant should use effective contraception.

Contraindications

Do not take milnacipran if you are allergic to milnacipran or any of the inactive ingredients in the tablet. The medication is contraindicated with monoamine oxidase inhibitors (MAOIs), including linezolid and intravenous methylene blue. Do not start an MAOI within 14 days of stopping milnacipran, and do not start milnacipran within 14 days of stopping an MAOI. This combination can cause a life-threatening condition called serotonin syndrome. Milnacipran is contraindicated in patients with uncontrolled narrow-angle glaucoma, because it can raise intraocular pressure. It should not be used in patients with uncontrolled hypertension or severe or unstable coronary heart disease, as the increase in blood pressure and heart rate could worsen these conditions. Do not use milnacipran during breastfeeding. It is not approved for use in children or adolescents under 18 years of age. If you have severe kidney impairment, the dose must be adjusted, and the drug should be used with caution. Do not take milnacipran if you are taking any other SNRI or SSRI, or any other drug that increases serotonin, without close medical supervision.

Possible Side Effects

More than 1 in 10 people experience nausea, headache, constipation, dizziness, insomnia, hot flushes, and increased sweating. These effects are most common when starting treatment or increasing the dose, and they often ease after a few weeks. Nausea is the most frequent complaint, affecting about 15 to 20 percent of people in clinical trials. Taking the tablet with food may help. Other common side effects include dry mouth, palpitations, vomiting, abdominal pain, and fatigue. Some people notice increased heart rate or a feeling of a pounding heart. This is usually mild but should be reported if it is bothersome or persistent. Serious side effects are less common but require immediate medical attention. These include serotonin syndrome, with agitation, confusion, rapid heartbeat, muscle rigidity, and sweating; neuroleptic malignant syndrome, with high fever, muscle stiffness, and altered mental state; severe liver injury, with jaundice, dark urine, and right upper abdominal pain; hyponatremia, with headache, confusion, and weakness; and abnormal bleeding, with easy bruising or unusual bleeding. Suicidal thoughts or behaviour can occur, especially in young adults during the first weeks of treatment. If you develop a rash, swelling of the face or throat, or difficulty breathing, seek emergency care. Most side effects from milnacipran are manageable, but any symptom that concerns you should be reported to your doctor.

Drug Interaction

Milnacipran has a relatively low potential for interactions with drugs that are metabolized by the liver, because it does not inhibit or induce cytochrome P450 enzymes to a significant degree. That is one of its advantages over some other antidepressants. However, there are important interactions to know about. Do not take milnacipran with MAO inhibitors, linezolid, or intravenous methylene blue, because of the risk of serotonin syndrome. Do not take it with other SNRIs, SSRIs, tricyclic antidepressants, triptans, fentanyl, tramadol, or St. John's wort, because these also increase serotonin and the combination can be dangerous. If you take NSAIDs, aspirin, or warfarin, the risk of bleeding increases. Your doctor may need to monitor you more closely. Milnacipran can raise blood pressure, and taking it with other drugs that increase blood pressure has not been well studied. Use caution if you take stimulants, decongestants, or other medications that raise blood pressure. Alcohol should be avoided, as it can increase the risk of liver damage and add to drowsiness. Tell your doctor and pharmacist about every medication you take, including over-the-counter products and supplements.

Missed Dose

If you miss a dose of Savella, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Your body may need time to readjust, and your doctor may want you to start at a lower dose again.

Overdose

Overdose with milnacipran can be dangerous. Symptoms may include severe drowsiness, confusion, agitation, hallucinations, fast or irregular heartbeat, high or low blood pressure, nausea, vomiting, and seizures. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of heart rhythm and vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Savella tablets at room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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