Savella

The active ingredient in Savella is milnacipran hydrochloride. It is an SNRI, or serotonin and norepinephrine reuptake inhibitor. It's unclear how the drug treats fibromyalgia. However, it increases the levels of serotonin and norepinephrine in the brain. These neurotransmitters may help regulate pain.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Savella. However, the following is a synopsis of the general guidelines for the use of Savella:

• You can take this medicine with or without food, although eating may help you tolerate the medication better.
• Your blood pressure and heart rate will need to be monitored frequently.
• Inform your doctor if you have any changes in sexual function, such as a lack of desire in sex, difficulty having an orgasm, or (in men) issues with erections or ejaculation. Some sexual disorders are treatable.
• Combining Savella with other drowsiness-inducing medications can exacerbate this effect. Consult your doctor before taking an opioid, a sleeping pill, a muscle relaxant, or medication for anxiety or seizures.

The most common side effects of Savella seen in clinical trials as compared to placebo include:

• Nausea.
• Headache.
• Dry mouth.
• Constipation.
• Trouble sleeping.
• Dizziness.
• Palpitations.
• Hot flushes.
• Sexual problems.
• Increased blood pressure.

Some individuals may experience serious side effects while using Savella. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Increased risk of worsening depression and suicidal thoughts or behaviour.
• Serotonin syndrome symptoms include fever, perspiration, mobility issues, discomfort, and hallucinations.
• Liver damage symptoms include yellowing of the skin or eyes, upper stomach pain, and black urine.
• Low sodium levels that can cause headaches, difficulties concentrating, memory issues, disorientation, weakness, unsteadiness, hallucinations, fainting, and seizures.
• Bleeding or bruising symptoms include unusual bleeding or bruising, persistent bleeding or bruising, nosebleeds, and blood in your urine or stool.
• Increased risk of bleeding.
• Seizures.
• Worsening glaucoma. Notify your provider if you have blurred vision, severe eye pain, see halos around lights, or a headache.

These are not all of the possible side effects of Savella. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Savella, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver disease or liver problems.
• Increased liver enzymes.
• Kidney disease.
• Cardiovascular disease or high blood pressure (hypertension).
• Epilepsy.
• Bipolar disorder is often known as manic depression.
• Bleeding problems.
• Your blood has low quantities of salt.
• Major depressive disorder.
• Sexual issues.
• If you consume alcohol.
• If you take a blood thinner, such as warfarin (Coumadin or Jantoven).
• If you are taking or have taken an MAO inhibitor within the last 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. After you stop using milnacipran, you must wait at least 5 days before taking an MAOI.

Boxed Warning

Antidepressants have been shown in short-term trials to raise the risk of suicidal thoughts and behaviour in children, adolescents, and young adults under the age of 24, although this risk is not shown in older adults and may even reduce in those above the age of 65. As a result, young kids should be constantly followed, particularly during the first 1-2 months or during dose adjustments, and families should report any unexpected behavioural changes. If deteriorating conduct or suicidal ideation arises, treatment may need to be discontinued. These medications are not approved for use in paediatric patients.

Taking a monoamine oxidase inhibitor (MAOI) now or within the previous 14 days.

In clinical tests, several participants stated that their pain was "much" or "very much" better after just one week of taking Savella at a consistent dose. Others, however, may not notice the full results for several months. Consult your doctor if you don't get any relief from fibromyalgia pain after several weeks or months of using the medicine.

When Savella is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Tramadol.
• Duloxetine.
• Tricyclic antidepressants (TCAs).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, or aspirin.
• St. John’s Wort.
• Buspirone.
• Lithium.
• Selective serotonin reuptake inhibitors (SSRIs).
• Tryptophan.
• Amphetamines.
• Pregabalin.
• Triptans.

You'll normally start with a low dose of Savella (milnacipran). Then, your prescriber will gradually titrate your dose up over the course of a week until you reach a maintenance dose.

Day 1: Take 12.5 mg orally once daily.

Days 2–3: Take 12.5 mg by mouth twice daily.

Days 4–7: Take 25 mg by mouth twice daily.

After day 7 (maintenance dose), take 50 mg by mouth twice daily.

If you require greater pain relief, your doctor may increase your maintenance dose to 100 mg twice daily.

If you have significant kidney problems, your maintenance dosage may differ.

Store at room temperature and keep out of reach of children. Savella is only used for patients over 18 years of age.

AbbVie is the pharmaceutical company that manufactures Savella.

There are no lower-cost generic versions available of Savella.

Do not stop taking Savella abruptly, as it may cause some withdrawal symptoms. Speak to your healthcare provider first before changing your dose or stopping this medication.

Using this medication during pregnancy may result in serious breathing problems or other complications for the baby. If you become pregnant, tell your doctor right away. Do not start or stop taking this medication during pregnancy without consulting your doctor.

If you took the medication during pregnancy, you can join the Savella Pregnancy Registry to monitor the effects of milnacipran on you and the baby.

Savella is found in breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. If your infant is exposed to Savella through breastfeeding, they should be monitored for agitation, irritability, poor feeding, and poor weight gain.