Lefluniclo

LEFLUNICLO- leflunomide and diclofenac sodium gel
V2 Pharma, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

(NDC 72835-602-02)
Rx Only

LEFLUNICLO DESCRIPTION

LEFFLUNICLO is supplied as 2 components in a kit:

1 BOTTLE OF LEFLUNOMIDE TABLETS USP; 20MG (30 TABLETS) White to off-white, round film coated tablet, debossed with “L” on one side and “A5” on the other side.

1 TUBE OF DICLOFENAC SODIUM (NSAID*) 1% (equivalent to 0.93% diclofenac), 100 g TUBE.

INDICATION AND USAGE

For the treatment of adults with active rheumatoid arthritis (RA). For the temporary relief of arthritis pain.

DOSAGE AND ADMINISTRATION

SEE PRESCRIBING DIRECTIONS FOR EACH COMPONENT CONTAINED IN THIS KIT

Take one leflunimide 20 mg once daily. The maximum recommended daily dosage is 20 mg once per day.

Apply 2-4 grams of diclofenac 1% gel to treated area as needed up to 4 times per day. Do not usea on more than 2 body areas at the same time.

CONTRADICTIONS

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.

PRECAUTIONS

Keep this and all other medications out of the reach of children. Please read all precautions of each component within this kit.

PREGNANCY

If pregnant or breast feeding, ask a health professional before use.

Store at 20°-25°C (68° to 77°F); Keep away from heat and flame. Protect from freezing. [See USP Controlled Room Temperature.] Protect from light.

MANUFACTURED FOR:
V2 Pharma, LLC
Hudson, MI
Rx Only

Leflunomide 20mg

RX Only

1 INDICATIONS AND USAGE

Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).

These highlights do not include all the information needed to use. See full prescribing information for and Initial U.S. Approval

“These highlights do not include all the information needed to use” “see full prescribing information for” and “Initial U.S. Approval”

2.1 Recommended Dosage

The recommended dosage of leflunomide tablets USP is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient’s risk of leflunomide tablets USP -associated hepatotoxicity and leflunomide tablets -associated myelosuppression. The loading dosage provides steady-state concentrations more rapidly.
For patients who are at low risk for leflunomide tablets -associated hepatotoxicity and leflunomide tablets USP — associated myelosuppression the recommended leflunomide tablets USP loading dosage is 100 mg once daily for 3 days. Subsequently administer 20 mg once daily.
For patients at high risk for leflunomide tablets USP -associated hepatotoxicity (e.g., those taking concomitant methotrexate) or leflunomide tablets -associated myelosuppression (e.g., patients taking concomitant immunosuppressants), the recommended leflunomide tablets USP dosage is 20 mg once daily without a loading dose [see Warnings and Precautions (5.2,5.4)].
The maximum recommended daily dosage is 20 mg once per day. Consider dosage reduction to 10 mg once daily for patients who are not able to tolerate 20 mg daily (i.e., for patients who experience any adverse events listed in Table 1).

Monitor patients carefully after dosage reduction and after stopping therapy with leflunomide tablets, since the active metabolite of leflunomide, teriflunomide, is slowly eliminated from the plasma [see Clinical Pharmacology (12.3)]. After stopping leflunomide tablets treatment, an accelerated drug elimination procedure is recommended to reduce the plasma concentrations of the active metabolite, teriflunomide [see Warnings and Precautions (5.3)]. Without use of an accelerated drug elimination procedure, it may take up to 2 years to reach undetectable plasma teriflunomide concentrations after stopping leflunomide tablets [see Clinical Pharmacology (12.3)].

2.2 Evaluation and Testing Prior to Starting leflunomide tablets USP

Prior to starting leflunomide tablets treatment the following evaluations and tests are recommended:

3 DOSAGE FORMS AND STRENGTHS

Tablets: 20 mg, supplied as Yellow colour, film coated, round shaped tablet, debossed with “L” on one side and “A5” on the other side

4 CONTRAINDICATIONS

Leflunomide tablet is contraindicated in:
Pregnant women. Leflunomide tablets may cause fetal harm. If a woman becomes pregnant while taking this drug, stop leflunomide tablets, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see Warnings and Precautions (5.1 and 5.3) and Use in Specific Populations (8.1)].
Patients with severe hepatic impairment [see Warnings and Precautions (5.2)].
Patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. Known reactions include anaphylaxis [see Adverse Reactions (6.1)].
Patients being treated with teriflunomide [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

Leflunomide tablets may cause fetal harm when administered to a pregnant woman. Teratogenicity and embryo-lethality occurred in animal reproduction studies with leflunomide at doses lower than the human exposure level [see Use in Specific Populations (8.1)].
Leflunomide tablet is contraindicated for use in pregnant women [see Contraindications (4)]. Exclude pregnancy before starting treatment with leflunomide tablets in females of reproductive potential [see Dosage and Administration (2.2)]. Advise females of reproductive potential to use effective contraception during leflunomide tablets treatment and during an accelerated drug elimination procedure after leflunomide tablets treatment [see Use in Specific Populations (8.3)]. If a woman becomes pregnant while taking leflunomide tablets, stop treatment with leflunomide tablets, apprise the patient of the potential risk to a fetus, and perform an accelerated drug elimination procedure to achieve non-detectable plasma concentrations of teriflunomide, the active metabolite of leflunomide [see Warnings and Precautions (5.3)].
Upon discontinuing leflunomide tablets, it is recommended that all females of reproductive potential undergo an accelerated drug elimination procedure. Women receiving leflunomide tablets treatment who wish to become pregnant must discontinue leflunomide tablets and undergo an accelerated drug elimination procedure, which includes verification that plasma concentrations of the active metabolite of leflunomide, teriflunomide, are less than 0.02 mg/L (0.02 mcg/mL). Based on animal data, human plasma concentrations of teriflunomide of less than 0.02 mg/L (0.02 mcg/mL) are expected to have minimal embryo-fetal risk [see Contraindications (4), Warnings and Precautions (5.3), and Use in Specific Populations (8.1)].