Eye Therapies Exhibit 2129, 1 of 4
`Slayback v. Eye Therapies - IPR2022-00142
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`7/8/22, 9:56 AM
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`Slayback Pharma announces launch of Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsule…
`Ajay Singh, CEO of Slayback Pharma, said, "Slayback's launch has triggered
`the 180-day CGT exclusivity period for Merzee. We continue to remain
`focused on bringing high quality and affordable generics to the US market."
`
`Merzee is available for shipment and can be ordered through your
`wholesaler/distributor.  Please contact our customer service team at 1-844-
`566-2505.
`
`See the following important safety information and refer to the package
`insert for full prescribing information.
`
`What is Merzee Used for?
`Merzee is an oral estrogen/progestin combination oral contraceptive (COC)
`used by women to prevent pregnancy.  One capsule is taken daily in order
`as provided in the blister pack. The efcacy of Merzee in women who are
`obese (mass index (BMI) of > 35 kg/m ) has not been evaluated .
`2
`1
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`Important Safety Information for Merzee
`
`WARNING CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
`See Full Prescribing Information for complete boxed warning.
`• Women over 35 years old who smoke should not use Merzee.
`• Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive
`(COC) use.
`
`Do not use Merzee if you:
`
`have had blood clots, a heart attack or stroke, uncontrolled high blood
`pressure
`have liver tumors or liver disease
`have unexplained vaginal bleeding
`are pregnant
`have had breast cancer or other estrogen- or progestin-sensitive
`cancer
`are taking Hepatitis C drugs containing ombitasvir/
`paritaprevir/ritonavir, with or without dasabuvir
`Allergic to any of the ingredients in Merzee
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`Stop using and discuss with your doctor before restarting:
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`https://www.prnewswire.com/news-releases/slayback-pharma-announces-launch-of-merzee-norethindrone-acetate-and-ethinyl-estradiol-capsules-and… 2/4
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`Eye Therapies Exhibit 2129, 2 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`7/8/22, 9:56 AM
`
`
`
`Slayback Pharma announces launch of Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsule…
`if a blood clotting occurs or an unexplained change or loss of vision
`occurs.
`at least 4 weeks before through 2 weeks after major surgery. Start no
`earlier than 4 weeks after delivery, or if you are breastfeeding.
`if you develop liver disease or yellowing of the shin or eyes occurs.
`if you have a history of or develop problems with your gallbladder
`if you are prediabetic or diabetic and should be monitored by your
`doctor
`have uncontrolled carbohydrate and lipid (fat) metabolic effects,
`discuss an alternative method of birth control with your doctor.
`if you have signicant changes in headaches.
`if you have unusual or absent vaginal bleeding
`
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`Possible side effects
`The most serious adverse events or side effects which could be life-
`threatening or lead to permanent disability are:
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`cardiovascular events such as heart attack and stroke
`vascular problems such as clotting in lungs and deep veins
`liver disease
`
`
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`
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`The most common adverse reactions reported are:
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`irregular vaginal bleeding
`nausea
`breast tenderness
`headache
`
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`
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`Merzee may cause decreased milk production in breastfeeding women.
`
`In clinical trials the most common reported side effects were: headache,
`vaginal infections, nausea, menstrual cramps, breast tenderness, bacterial
`vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
`
`Drug Interactions
`Drugs like Merzee have seriously decreased the effects of thyroid hormone
`replacement drugs and lamotrigine. Do not take Merzee with hepatitis
`drugs containing ombitasvir/ paritaprevir/ritonavir, with or without
`dasabuvir.
`
`Drugs or herbal products that trigger certain enzymes, including CYP3A4,
`may decrease the effectiveness of drugs like Merzee or increase
`breakthrough bleeding. Patients should use a back-up method or
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`https://www.prnewswire.com/news-releases/slayback-pharma-announces-launch-of-merzee-norethindrone-acetate-and-ethinyl-estradiol-capsules-and… 3/4
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`Eye Therapies Exhibit 2129, 3 of 4
`Slayback v. Eye Therapies - IPR2022-00142
`
`

`

`7/8/22, 9:56 AM
`
`Slayback Pharma announces launch of Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsule…
`alternative method of contraception when these products are used with
`Merzee and other COCs.
`
`You may report an adverse event related to Merzee made by Slayback
`Pharma by calling 1-844-566-2505 or emailing medical@slayback-
`pharma.com.  If you prefer, you may contact the U.S. Food and Drug
`Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.
`
`References:
`Merzee full Prescribing Information . Slayback Pharma, 01/2021
`(1)
`Taytulla® is a registered trademark of Allergan Pharmaceuticals
`International Limited
`
`SOURCE Slayback Pharma LLC
`
`Related Links
`http://www.slayback-pharma.com
`
`https://www.prnewswire.com/news-releases/slayback-pharma-announces-launch-of-merzee-norethindrone-acetate-and-ethinyl-estradiol-capsules-and… 4/4
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`Eye Therapies Exhibit 2129, 4 of 4
`Slayback v. Eye Therapies - IPR2022-00142
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