CLARAVIS- isotretinoin capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

ISOTRETINOIN

Composition:

ISOTRETINOIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Claravis (isotretinoin capsules) is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Claravis should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Claravis is indicated only for those patients who are not pregnant, because Claravis can cause life threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to

Product summary:

Claravis™ (isotretinoin capsules USP) is available as: 10 mg: Two-piece hard gelatin capsule with light gray opaque cap and light gray opaque body filled with yellow oily dispersion. Imprinted in red ink barr on one piece and 934 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1054-86) and 100 capsules containing 10 prescription blister packs of 10 capsules (NDC 0555-1054-56). 20 mg: Two-piece hard gelatin capsule with brown opaque cap and brown opaque body filled with yellow oily dispersion. Imprinted in white ink barr on one piece and 935 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1055-86) and 100 capsules containing 10 prescription blister packs of 10 capsules (NDC 0555-1055-56). 30 mg: Two-piece hard gelatin capsule with orange opaque cap and orange opaque body filled with yellow oily dispersion. Imprinted in black ink barr on one piece and 454 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1056-86). 40 mg: Two-piece hard gelatin capsule with light orange opaque cap and light orange opaque body filled with yellow oily dispersion. Imprinted in black ink barr on one piece and 936 on the other piece. Available in cartons of 30 capsules containing 3 prescription blister packs of 10 capsules (NDC 0555-1057-86) and 100 capsules containing 10 prescription blister packs of 10 capsules (NDC 0555-1057-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLARAVIS- ISOTRETINOIN CAPSULE, LIQUID FILLED
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
CLARAVIS™ (klar-uh-vis)
(isotretinoin capsules USP)
Rx only
Read the Medication Guide that comes with Claravis before you start
taking it and each time you get a
prescription. There may be new information. This information does not
take the place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about Claravis?
•
Claravis is used to treat a type of severe acne (nodular acne) that
has not been helped by other
treatments, including antibiotics.
•
Because Claravis can cause birth defects, Claravis is only for
patients who can understand and agree
to carry out all of the instructions in the iPLEDGE REMS.
•
Claravis may cause serious mental health problems.
1. Birth defects (deformed babies), loss of a baby before birth
(miscarriage), death of the baby, and early
(premature) births. Patients who are pregnant or who plan to become
pregnant must not take Claravis.
Patients must not get pregnant:
•
for 1 month before starting Claravis
•
while taking Claravis
•
for 1 month after stopping Claravis.
If you become pregnant while taking Claravis, stop taking it right
away and call your doctor. Doctors and
patients should report all cases of pregnancy to:
•
FDA MedWatch at 1-800-FDA-1088, and
•
The iPLEDGE Pregnancy Registry at 1-866-495-0654
2. Serious mental health problems. Claravis may cause:
•
depression
•
psychosis (seeing or hearing things that are not real)
•
suicide. Some patients taking Claravis have had thoughts about hurting
themselves or putting an end
to their own lives (suicidal thoughts). Some people tried to end their
own lives. And some people
have ended their own lives.
Stop Claravis and call your doctor right away if you or a family
member notices that you have any of the
following signs and symptoms of depression or psychosis:
•
start to feel sad or have crying spells
•
lose interest in activities

Summary of Product characteristics

CLARAVIS- ISOTRETINOIN CAPSULE, LIQUID FILLED
TEVA PHARMACEUTICALS USA, INC.
----------
CLARAVIS
(ISOTRETINOIN CAPSULES USP)
CAUSES BIRTH
DEFECTS
DO NOT GET
PREGNANT
RX ONLY
™
CONTRAINDICATIONS AND WARNINGS
CLARAVIS MUST NOT BE USED BY PATIENTS WHO ARE OR MAY BECOME
PREGNANT. THERE IS AN EXTREMELY HIGH RISK THAT LIFE-THREATENING BIRTH
DEFECTS WILL RESULT IF PREGNANCY OCCURS WHILE TAKING CLARAVIS IN ANY
AMOUNT, EVEN FOR SHORT PERIODS OF TIME. POTENTIALLY ANY FETUS EXPOSED
DURING PREGNANCY CAN BE AFFECTED. THERE ARE NO ACCURATE MEANS OF
DETERMINING WHETHER AN EXPOSED FETUS HAS BEEN AFFECTED.
BIRTH DEFECTS WHICH HAVE BEEN DOCUMENTED FOLLOWING ISOTRETINOIN
EXPOSURE INCLUDE ABNORMALITIES OF THE FACE, EYES, EARS, SKULL, CENTRAL
NERVOUS SYSTEM, CARDIOVASCULAR SYSTEM, AND THYMUS AND PARATHYROID
GLANDS. CASES OF IQ SCORES LESS THAN 85 WITH OR WITHOUT OTHER
ABNORMALITIES HAVE BEEN REPORTED. THERE IS AN INCREASED RISK OF
SPONTANEOUS ABORTION, AND PREMATURE BIRTHS HAVE BEEN REPORTED.
DOCUMENTED EXTERNAL ABNORMALITIES INCLUDE: SKULL ABNORMALITY; EAR
ABNORMALITIES (INCLUDING ANOTIA, MICROPINNA, SMALL OR ABSENT EXTERNAL
AUDITORY CANALS); EYE ABNORMALITIES (INCLUDING MICROPHTHALMIA); FACIAL
DYSMORPHIA; CLEFT PALATE. DOCUMENTED INTERNAL ABNORMALITIES INCLUDE:
CNS ABNORMALITIES (INCLUDING CEREBRAL ABNORMALITIES, CEREBELLAR
MALFORMATION, HYDROCEPHALUS, MICROCEPHALY, CRANIAL NERVE DEFICIT);
CARDIOVASCULAR ABNORMALITIES; THYMUS GLAND ABNORMALITY; PARATHYROID
HORMONE DEFICIENCY. IN SOME CASES DEATH HAS OCCURRED WITH CERTAIN OF
THE ABNORMALITIES PREVIOUSLY NOTED.
IF PREGNANCY DOES OCCUR DURING TREATMENT OF A PATIENT WHO IS TAKING
CLARAVIS, CLARAVIS MUST BE DISCONTINUED IMMEDIATELY AND THE PATIENT
SHOULD BE REFERRED TO AN OBSTETRICIAN-GYNECOLOGIST EXPERIENCED IN
REPRODUCTIVE TOXICITY FOR FURTHER EVALUATION AND COUNSELING.
SPECIAL PRESCRIBING REQUIREMENTS
BECAUSE OF ISOTRETINOIN'S TERATOGENICITY AND TO MINIMIZE FETAL
EXPOSURE,
CLARAVIS IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED
DISTRIBUTION PROGRAM APPROVED BY THE FOOD A