Kurvelo (Page 3 of 5)

OVERDOSAGE

There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.

DOSAGE AND ADMINISTRATION

1.How to Start and Take Kurvelo

Kurvelo is dispensed in a compact dispenser containing 28 tablets (see HOW SUPPLIED). Kurvelo may be started using either a Day 1 start or a Sunday start (see Table 3). For the first cycle of a Sunday start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

Table 3: Instructions for Administration of Kurvelo
Starting Kurvelo in females with no current use of hormonal contraception Day 1 start • Take first tablet without regard to meals on the first day of menses • Take subsequent tablets once daily at the same time each day • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet)
Sunday start • Take first tablet without regard to meals on the first Sunday after the onset of menstrual period • Take subsequent tablets once daily at the same time each day • Use additional nonhormonal contraception for the first seven days of product use • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet)
Switching from another contraceptive method A COC Start Kurvelo: • On the day when the new pack of the previous COC would have been started
Transdermal patch • On the day when next application would have been scheduled
Vaginal ring • On the day when next insertion would have been scheduled
Injection • On the day when next injection would have been scheduled
Intrauterine contraceptive • On the day of removal
Implant • On the day of removal

Starting Kurvelo after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, Kurvelo may be started immediately. An additional method of contraception is not needed if Kurvelo is started immediately.
  • If Kurvelo is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle of Kurvelo.

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Kurvelo following the instructions in Table 3 for Day 1 or Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle of Kurvelo (see CONTRAINDICATIONS, WARNINGS (1), PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING).

Starting Kurvelo after Childbirth

2.Dosing Kurvelo

Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take Kurvelo as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.

3.Missed doses

Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling.

Table 4: Instructions for Missed Kurvelo Tablets
• If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.
• If two active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
• If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start: Throw out the rest of the pack and start a new pack that same day.Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.

4.Advice in Case of Gastrointestinal Disturbances

If vomiting occurs within 3 to 4 hours after taking Kurvelo, the patient should proceed as if she missed a tablet. In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.

HOW SUPPLIED/STORAGE AND HANDLING

Kurvelo Tablets (levonorgestrel and ethinyl estradiol tablets USP) (3 x 28) are available in packages of 3 blisters, each containing 28 tablets as follows:

Each blister strip contains 21 light orange tablets, each containing of 0.15 mg levonorgestrel and 30 mcg ethinyl estradiol, debossed with “LU” on one side and “U31” on the other side.

7 inert pink, round, biconvex tablets, debossed with “LU” on one side and “U32” on the other side.

They are supplied as follows:

Kurvelo tablets are available in a blister (NDC 68180-844-71) containing 28 tablets, such 3 blisters are packed in a carton (NDC 68180-844-73).

Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature].

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775

INDIA

Revised: April 2023

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