Brand & Generic Names; Drug Classes
|US brand name: Savella|
|Generic name: milnacipran|
|Primary drug class: Migraine/NeuropathicPain|
|Additional drug class(es): Antidepressants, Serotonin and Norepinephrine Reuptake Inhibitors|
Approved & Off-Label Uses (Indications)
Savella’s US FDA Approved Treatment(s)
Management of fibromyalgia. Approved 14 January 2009.
Uses Approved Overseas but not in the US
- Most places in the world Ixel/Dalcipran is only an antidepressant.
- In France Ixel / Dalcipran is approved to treat both MDD and fibromyalgia.
- In Japan Toledomin is approved to treat acute (short-term) and chronic (long-term) MDD as well as fibromyalgia.
Off-Label Uses of Savella
When & If Savella Will Work
Savella’s Usual Onset of Action (when it starts working)
Like any SNRI, expect Savella / Ixel to start working in 2 to 4 weeks.
Likelihood of Working
Not all that great. But in all fairness, nothing works all that great when it comes to fibro. In the clinical trials and other double-blind studies around 35% of the people (mostly, if not entirely women) did experience greater than a 50% reduction in pain. Often much greater. So when Savella / Ixel works it can really work. However there was a significant drop-out rate in the people taking the drug. Usually twice as high as the placebo. And not always for side effects. So factoring in the drop-out rate, you have about a 1-in-4 chance that Savella / Ixel will work for you.
I don’t know if this is fibromyalgia-specific, but if you’re still puking your guts out or dealing with other side effects that usually go away for SNRIs at week 4, just give up on Savella / Ixel. I think Stahl was on autopilot when he typed “Wait. Wait. Wait.” in how to deal with milnacipran’s side effects. Unless your doctor has you at 200 mg a day already. But lowering the dosage doesn’t help with the side effects that much and it still isn’t working, just move on.
One thing I’m noticing in reports from consumers: doctors are switching their patients from Cymbalta to Savella and the people are reporting SSRI/SNRI discontinuation syndrome. My money is on the doctors being idiots and having their patients go from 60 mg a day of Cymbalta to 25 mg a day of Savella with no cross-taper/titration (where you simultaneously decrease the amount of one drug and increase the amount of another). No wonder they feel like shit. Savella is taking the blame for their brain zaps and other discontinuation symptoms.
There aren’t enough data. I guess all the other SNRIs had the market cornered. I’m surprised Savella wasn’t used more often for depression prior to Fetzima’s approval.
Taking and Discontinuing
How to Take Savella
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).
Based on efficacy and tolerability dosing may be titrated according to the following schedule:
12.5 mg once
25 mg/day (12.5 mg twice daily )
50 mg/day (25 mg twice daily )
After Day 7:
100 mg/day (50 mg twice daily )
Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily)
I don’t think so, Forest.
- I could take Savella without food and without a problem, but my stomach has yet to meet a med it didn’t like. Based upon reality, people should start taking it with food and figure out later if they need to keep doing so.
- Have I told you how much I dislike target dosages? Sometimes they’re a good idea, sometimes they’re not. With this type of drug (an SNRI) and these applications (fibromyalgia and depression), the Crazymeds rules are:
- Start low
- Increase slowly
- Stay at the dosage where your symptoms stop.
- Given the ridiculously short half-lives and other PK factors, taking a single 12.5 mg tablet on day one then two of them the next day makes perfect sense.
- If you want to do that for another day or two to acclimate to side effects, sure. Just don’t start waiting for it to take effect until you’re taking it twice a day.
- Just make damn sure you take it at the same time every day. ± one hour at the most.
- After that, I’d double the length of time involved.
- I’d just round it up to a week to make it easier to remember.
- So that would be 25 mg a day the first weeks, 50 mg a day the second and 100 mg a day the third.
- Depending on your history with meds, you may want to make that 75 mg a day for the third week and 100 mg a day the fourth.
- That could be expensive, as it would require taking two 25 mg and two 12.5 mg tablets a day.
- Unless your symptoms stopped. At whatever dosage your symptoms stopped, that’s the dosage you want to be at.
If you’re currently taking Cymbalta, another SNRI or an SSRI and your doctor tells you to stop taking your current medication all at once the same day you take that first 12.5 mg of Savella, find another doctor!!! You need to either lower the dosage of the med you’re now taking as you increase the dosage of Savella, or slowly discontinue whatever you’re taking now prior to starting Savella. There are pros and cons to each method. A good doctor would work with you to figure out the better option.
How to Stop Taking Savella (discontinuation / withdrawal)
Oh, this is rich.
2.4 Discontinuing Savella
Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].
During marketing of milnacipran, and other SNRIs and SSRIs, there have been spontaneous reports of adverse events indicative of withdrawal and physical dependence occurring upon discontinuation of these drugs, particularly when discontinuation is abrupt. The adverse events include the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Although these events are generally self-limiting, some have been reported to be severe.
Patients should be monitored for these symptoms when discontinuing treatment with Savella. Savella should be tapered and not abruptly discontinued after extended use. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate [see Dosage and Administration (2.4)]. --the Savella PI sheet
Thank you, Captain Obvious!
Our rule of thumb is to discontinue a med at either the same rate you titrated (the schedule of dosage increases), or by reducing the dosage by whatever the typical dosage increase amount is every however long the clearance is (usually half-life times five). If you followed the recommended schedule for Savella you DO NOT want to decrease what you’re taking at the same rate. Even though that approximates the half-life times five model.
What you want to do is decrease your dosage by 25 mg a day per week. You’ll need 12.5 mg tablets to do this. So if you’re at 100 mg a day that’s 75 mg a day week one, 50 mg a day week two, 25 mg a day week three, and you may need a day or two where you take a single 12.5 mg.
If you’re experiencing really bad discontinuation syndrome symptoms, then get a prescription for 12.5 mg tablets and decrease your dosage by 12.5 mg a day per week.
Savella tablets are film-coated and they aren’t scored, so it’s not a good idea to split them.