2.1 How to Start Using TWIRLA

See the FDA-approved patient labeling (Instructions for Use).

The TWIRLA transdermal system (TDS) is used in a 28-day (four-week) cycle. A new TDS is applied and worn for seven days for three consecutive weeks (Weeks 1, 2, and 3). No TDS is worn during Week 4 (the TDS-Free Week), when withdrawal bleeding is expected.

On the day after Week 4 ends, a new 28-day cycle is started by applying a new TDS. Under no circumstances should there be more than a 7-day TDS-free interval between dosing cycles.

Breakthrough (Unscheduled) Bleeding or Spotting Occurrence
If unscheduled (breakthrough) spotting or bleeding occurs, instruct the woman to continue the same regimen. If the bleeding is persistent or prolonged consider causes other than TWIRLA. If the bleeding is persistent or prolonged, instruct the woman to consult with her healthcare provider.

In Case of Skin Irritation
If TDS use results in uncomfortable irritation, the TDS may be removed, and a new TDS may be applied to a different location until the next “Patch Change Day”. Only one TDS should be worn at a time.

Every new TDS should be applied on the same day of the week. This day is known as the “Patch Change Day.” For example, if the first TDS is applied on a Sunday, all subsequent TDS should be applied on a Sunday.

There are multiple options for starting the TDS, and the woman should choose the option that is most appropriate (see Table 1):

Use after an abortion or miscarriage:
TWIRLA may be started immediately for contraception within the first 5 days following a complete first trimester abortion or miscarriage without additional back-up contraception. If more than 5 days have elapsed from the first trimester abortion or miscarriage, then the woman should be advised to use non-hormonal contraception (such as condoms and spermicide, or diaphragm and spermicide) and follow instructions for starting TWIRLA for the first time. Ovulation may occur within 10 days of an abortion or miscarriage.

TWIRLA should not be started earlier than 4 weeks after a second trimester abortion or miscarriage due to the increased risk of thromboembolism [see Warnings and Precautions (5.1)].

Use of TWIRLA after childbirth:
For women who elect not to breastfeed, do not start TWIRLA sooner than 4 weeks after childbirth given the increased risk for thromboembolism [see Use in Specific Populations (8.2)].

If a woman begins using TWIRLA postpartum and has not yet had a period, consider the possibility of ovulation and pregnancy. If the woman is not pregnant, instruct her to use non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) for the first 7 days of TDS use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

2.2 Important Application Instructions

• See the FDA-approved patient labeling (Instructions for Use).
• TWIRLA TDS is applied once weekly for three weeks. Each TWIRLA TDS should be worn for one week. Instruct women to wear only one TWIRLA TDS at any time.
• To achieve maximum contraceptive effectiveness, TWIRLA must be used exactly as directed. The failure rate may increase when TDS application is delayed/missed or when TDS is applied incorrectly.
• Apply TWIRLA to clean, dry, and intact skin at the selected application site. Application sites include: the abdomen, buttock or upper torso (excluding the breasts). When applying a new TWIRLA TDS, do not apply the new TDS directly over the previous TDS site.
• Do not apply TWIRLA to skin that has been exposed to powder, oil, moisturizer, or lotion. Advise women not to routinely use large amounts of body lotions or oils at application sites.
• Prolonged exposure to water may interfere with adherence of TWIRLA.
• Do not cut or alter TWIRLA in any way, the whole TDS should be applied. If the TWIRLA TDS is cut or damaged or altered in size, contraceptive efficacy may be impaired.
• If the TWIRLA TDS lifts at the edges, reattach TWIRLA by pressing firmly and smoothing down the edges of the system. If TWIRLA comes off completely, reapply the TWIRLA TDS that detached.
• Discard TWIRLA by folding the used TDS so that the adhesive side sticks to itself and safely discard in the trash.

MANAGING PARTIAL OR COMPLETE TDS DETACHMENTS (see Table 2)
The TWIRLA TDS must adhere securely to the skin to work properly. Prolonged water exposure may compromise the TDS’s adherence. As a result, the woman should be instructed to check the TDS for partial or complete TDS detachment not only daily but also after prolonged water exposure.

If the TDS becomes partially or completely detached and remains detached, insufficient drug delivery may occur. Partial TDS detachment should be resolved since it can lead to the TDS getting caught on clothing and detaching. The woman should not try to reapply a TDS if it is no longer sticky, if it has become stuck to itself or another surface, and/or if it has other material stuck to it.

If a TDS edge lifts up:

• The woman should press down firmly on the TDS with the palm of the hand for 10 seconds, making sure that the whole TDS is adhered to her skin. Then run fingers over the entire surface area to smooth out any wrinkles around the edges of the TDS.
• If the lifted edge of the TDS does not stick completely after attempted re-adhesion, the TDS should be removed, and a new replacement TDS applied.
• Do not tape or wrap the TDS to the skin or reapply a TDS that is partially adhered to clothing.

If the TDS has been off or partially off:

• For less than one day, the woman should try to reapply it. If the TDS does not adhere completely, apply a new TDS immediately. No back-up contraception is needed and the “Patch Change Day” will stay the same.
• For more than one day OR if unsure of the timeframe, the woman may not be protected from pregnancy. To reduce this risk, apply a new TDS and start a new 4-week cycle. The woman will now have a new “Patch Change Day” and MUST USE NON-HORMONAL BACK-UP CONTRACEPTION (such as condoms and spermicide, or diaphragm and spermicide) for the first 7 days of the new cycle.

Missed Doses

Instruct women about the handling of missed doses (e.g., missed or delayed TDS application) and to follow the dosing instructions provided in the FDA-approved patient labeling.

FORGETTING TO CHANGE THE TDS:

• At the start of any TDS cycle (Week 1/Day 1): THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY. The woman should apply the first TDS of her new cycle as soon as she remembers, and this becomes the new "Patch Change Day" and a new "Day 1" of the cycle. The woman should use non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) for the first 7 days of the new cycle.
• In the middle of the TDS cycle (Week 2/Day 8 or Week 3/Day 15), for 1 or 2 days (up to 48 hours): The woman should apply a new TDS immediately. The next TDS should be applied on the usual "Patch Change Day". No back-up contraception is needed.
• For more than 2 days (48 hours or more): THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY. The woman should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new TDS. This is now a new "Patch Change Day" and a new "Day 1" of the cycle. Non-hormonal back-up contraception must be used for 7 days.
• At the end of the TDS cycle Week 3 (Day 22): If the woman forgets to remove her TDS, she should take it off as soon as she remembers. The next cycle should be started on the usual "Patch Change Day", which is the day after Day 28. No back-up contraception is needed.

Under no circumstances should there be more than a seven-day TDS-free interval between cycles. If there are more than 7 TDS-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY and non-hormonal back-up contraception (such as a condoms and spermicide, or diaphragm and spermicide) must be used for 7 days. As with CHCs, the risk of ovulation increases with each day beyond the recommended drug-free period. If the woman has intercourse during such an extended TDS-free interval, consider the possibility of pregnancy.