Savella (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

25-mg tablets:

White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse

Bottles of 60: NDC 0456-1525-60

50-mg tablets:

White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse

Bottles of 60: NDC 0456-1550-60

Storage

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

See Medication Guide

17.1 Information in Medication Guide

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 counsel them in its appropriate use. A patient Medication Guide is available for Savella. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Savella:

17.2 Suicide Risk

Patients and their families and caregivers should be advised that Savella is a selective norepinephrine and serotonin reuptake inhibitor and therefore belongs to the same class of drugs as antidepressants. Patients, their families and their caregivers should be advised that patients with depression may be at increased risk for clinical worsening and/or suicidal ideation if they stop taking anti-depressant medication, change the dose, or start a new medication.

Patients, their families and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania or other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during treatment with Savella or other drugs that inhibit the reuptake of norepinephrine and/or serotonin, and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. [see Box Warning and Warnings and Precautions (5.1)].

17.3 Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with concomitant use of Savella and triptans, tramadol, or other serotonergic agents [see Warnings and Precautions (5.2) ].

17.4 Effect on Blood Pressure and Pulse

Patients should be advised that their blood pressure and pulse should be monitored at regular intervals when receiving treatment with Savella [see Warnings and Precautions (5.3, 5.4)].

17.5 Abnormal Bleeding

Patients should be cautioned about the concomitant use of Savella and NSAIDs, aspirin, or other drugs that affect coagulation, since the combined use of agents that interfere with serotonin reuptake and these agents has been associated with an increased risk of abnormal bleeding [see Warnings and Precautions (5.9) ].

17.6 Ability to Drive and Use Machinery

Savella might diminish mental and physical capacities necessary to perform certain tasks such as operating machinery, including motor vehicles. Patients should be cautioned about operating machinery or driving motor vehicles until they are reasonably certain that Savella treatment does not affect their ability to engage in such activities.

17.7 Alcohol

Patients should be advised to avoid consumption of alcohol while taking Savella [see Warnings and Precautions (5.6, 5.13)].

17.8 Discontinuation

Patients should be advised that withdrawal symptoms can occur when discontinuing treatment with Savella, particularly when discontinuation is abrupt. [see Warnings and Precautions (5.7) ]

17.9 Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Savella therapy [see Use in Specific Populations (8.1) ].

Patients should be encouraged to enroll in the Savella Pregnancy Registry if they become pregnant, preferably before any prenatal testing is done. This registry is collecting information about the safety of milnacipran during pregnancy. To enroll, patients or their healthcare providers may call the toll free number 1-877-643-3010 [see Use in Specific Populations (8.1)], download data forms from our website, www.savellapregnancyregistry.com, or email the registry for further information at registries@kendle.com.

17.10 Nursing

Patients should be advised to notify their physician if they are breast-feeding [see Use in Specific Populations (8.3) ].

17.11 FDA-Approved Medication Guide

MEDICATION GUIDE
Savella® (Sa-vel-la) Tablets
(milnacipran HCl)

Antidepressant Medicines, Depression and other serious Mental Illnesses, and Suicidal Thoughts or Actions

Savella is not used to treat depression, but it acts like medicines that are used to treat depression (antidepressants) and other psychiatric disorders.

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts or actions with antidepressant medicines. Talk to your or your family member’s healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manicdepressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood
  • trouble sleeping (insomnia)

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: January 2009

Manufactured for:
Forest Pharmaceuticals, Inc.
Manufactured by:Forest Laboratories, Inc.

Licensed from Pierre Fabre Medicament and Cypress Bioscience, Inc.

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 25 MG LABEL

Rx Only

NDC 21695-650-60

Savella®

(milnacipran HCl) Tablets

25 mg

60 Tablets

Dispense the accompanying Medication

Guide to each patient.

FOREST PHARMACEUTICALS, INC.

Savella 25mg
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 50 MG LABEL

Rx only

NDC 21695-651-60

Savella®

(milnacipran HCl) Tablets

50 mg

60 Tablets

Dispense the accompanying Medication

Guide to each patient.

Forest Pharmaceuticals, Inc.

Savella 50mg
(click image for full-size original)

SAVELLA milnacipran hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-650(NDC:0456-1525)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
milnacipran hydrochloride (milnacipran) milnacipran hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate dihydrate
povidone
carboxymethylcellulose calcium
silicon dioxide
magnesium stearate
talc
HYPROMELLOSES
polyethylene glycol
titanium dioxide
Product Characteristics
Color white (white) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code FL;25;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-650-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022256 04/17/2009
SAVELLA milnacipran hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-651(NDC:0456-1550)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
milnacipran hydrochloride (milnacipran) milnacipran hydrochloride 50 mg
Inactive Ingredients
Ingredient Name Strength
dibasic calcium phosphate dihydrate
povidone
carboxymethylcellulose calcium
silicon dioxide
magnesium stearate
talc
fd&c blue no. 1
fd&c blue no. 2
fd&c yellow no. 5
HYPROMELLOSES
polyethylene glycol
titanium dioxide
Product Characteristics
Color green (green) Score no score
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code FL;50;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-651-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022256 04/17/2009
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 12/2010 Rebel Distributors Corp

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