Fetzima (Page 7 of 9)

16 HOW SUPPLIED/STORAGE AND HANDLING

FETZIMA extended-release capsules are supplied in the following configurations:

Capsule Strength Capsule Color/Shape Capsule Markings Package Configuration NDC Code
20 mg yellow capwhite body black “FL” on capblack “20” on body Bottle / 30 count 0456-2220-30
Hospital Unit Dose (Blister) / 10 x 10 0456-2220-63
40 mg yellow capyellow body black “FL” on capblack “40” on body Bottle / 30 count 0456-2240-30
Bottle / 90 count 0456-2240-90
Hospital Unit Dose (Blister) / 10 x 10 0456-2240-63
80 mg pink capwhite body black “FL” on capblack “80” on body Bottle / 30 count 0456-2280-30
Bottle / 90 count 0456-2280-90
Hospital Unit Dose (Blister) /10 x 10 0456-2280-63
120 mg pink cappink body black “FL” on capblack “120” on body Bottle / 30 count 0456-2212-30
Bottle / 90 count 0456-2212-90
Hospital Unit Dose (Blister) / 10 x 10 0456-2212-63

FETZIMA Titration Pack is supplied in the following configuration:

Capsule Strength Capsule Color/Shape Capsule Markings Package Configuration NDC Code
20 mg yellow capwhite body black “FL” on capblack “20” on body Titration Pack (Blister) containing two 20 mg capsules and twenty-six 40 mg capsules 0456-2202-28
40 mg yellow capyellow body black “FL” on capblack “40” on body

Storage and Handling

All package configurations: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicide Thoughts and Behaviors

Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [ see Boxed Warningand Warnings and Precautions ( 5.1) ].

Dosing and Administration

Advise patients that FETZIMA should be swallowed whole and should not be chewed, crushed, or opened.

Advise patients that FETZIMA can be taken with or without food.

Instruct patients if they miss a dose, to take the missed dose as soon as they remember. If it is almost time for the next dose, instruct them to skip the missed dose and take their next dose at the regular time. Advise them not to take two doses of FETZIMA at the same time.

Concomitant Medication

Instruct patients not to take FETZIMA with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping FETZIMA before starting an MAOI [ see Contraindications ( 4) ]. Advise patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for drug-drug interactions [ see Drug Interactions ( 7.1) ] .

Allergic Reactions

Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [ see Contraindications ( 4) ].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of FETZIMA with other serotonergic agents (including triptans, tricyclic antidepressants, opioids, lithium, amphetamines, tryptophan, buspirone, and St. John’s Wort supplements) [see Warnings and Precautions ( 5.2) and Drug Interactions ( 7.1)]. Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

E levated Blood Pressure and Heart Rate

Advise patients that they should have regular monitoring of blood pressure and heart rate when taking FETZIMA [ see Warnings and Precautions ( 5.3, 5.4) ].

Increased Risk of Bleeding

Caution patients about the concomitant use of FETZIMA and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation because combined use has been associated with an increased risk of bleeding. Advise patients to inform their healthcare provider if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions ( 5.5)].

Angle Closure Glaucoma

Patients should be advised that taking FETZIMA can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma [see Warnings and Precautions ( 5.6)].

Urinary Hesitation or Retention

Caution patients about the risk of urinary hesitation and retention while taking FETZIMA, particularly in patients prone to obstructive urinary disorders. Instruct patients to consult with their healthcare provider if they develop any problems with urine flow [ see Warnings and Precautions ( 5.7) ].

Activation of Mania/Hypomania

Advise patients and their caregivers to look for signs of activation of mania/hypomania [ see Warnings and Precautions ( 5.8) ].

Seizures

Caution patients about using FETZIMA if they have a history of a seizure disorder [see Warnings and Precautions ( 5.9)].

Discontinuation Syndrome

Advise patients not to abruptly stop taking FETZIMA without first talking with their healthcare provider. Patients should be aware that discontinuation effects may occur when suddenly stopping FETZIMA and they should monitor for discontinuation symptoms [ see Warnings and Precautions ( 5.10) ].

Hyponatremia

Advise patients that hyponatremia has been reported as a result of treatment with FETZIMA. Advise patients of the signs and symptoms of hyponatremia [ see Warnings and Precautions ( 5.11) ].

Sexual Dysfunction

Advise patients that use of FETZIMA may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [ see Warnings and Precautions ( 5.12)].

Alcohol

Advise patients to avoid consumption of alcohol while taking FETZIMA [see Drug Interactions ( 7.1) , Clinical Pharmacology ( 12.3) ].

Pregnancy

  • Advise pregnant females to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with FETZIMA.
  • Advise patients that FETZIMA may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding.
  • Advise patient that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FETZIMA during pregnancy [see Use in Specific Populations ( 8.1)]

Lactation

Advise breastfeeding patients using FETZIMA to monitor infants for sedation, agitation, irritability, poor feeding, and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.2)].

Interference with Cognitive and Motor Performance

Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that FETZIMA therapy does not adversely affect their ability to engage in such activities.

Distributed by:

AbbVie, Inc.
1 N Waukegan Rd.
North Chicago, IL 60064

©2023 AbbVie. All rights reserved.
FETZIMA and its design are trademarks of Pierre Fabre Medicament.Licensed from Pierre Fabre Medicament.

20081967

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