Lupaneta Pack

What is Lupaneta Pack?

Lupaneta Pack contains 2 different prescription medicines, leuprolide acetate for depot suspension is a medicine injected into your muscle and used to treat pain due to endometriosis. The second is norethindrone acetate tablets a medicine taken by mouth and used to help lower the side effect of bone thinning that is caused by leuprolide acetate for depot suspension.

Lupaneta Pack should not be used longer than 6 months at a time after you first start treatment for your endometriosis symptoms. Lupaneta Pack should not be used for more than a total of 12 months during your treatment.

It is not known if Lupaneta Pack is safe and effective in children under 18 years of age.

Description

LUPANETA PACK (leuprolide acetate for depot suspension; norethindrone acetate tablets) 1-month contains one dual chamber syringe with leuprolide acetate for depot suspension 3.75 mg and norethindrone acetate tablets USP: 5 mg (bottle of 30 tablets).

Leuprolide Acetate for Depot Suspension

Leuprolide acetate for depot suspension is a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH or LH-RH), a GnRH agonist. The chemical name is 5- oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:

Leuprolide acetate for depot suspension 3.75 mg is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection.

The front chamber of leuprolide acetate for depot suspension 3.75 mg prefilled dual-chamber syringe contains leuprolide acetate for depot suspension (3.75 mg), gelatin (0.65 mg), DL-lactic and glycolic acids copolymer (33.1 mg), and D-mannitol (6.6 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH.

During the manufacture of leuprolide acetate for depot suspension, acetic acid is lost, leaving the peptide.

Norethindrone Acetate

Norethindrone acetate tablets USP – 5 mg oral tablets.

Norethindrone acetate USP, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.

Norethindrone acetate tablets USP, 5 mg contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc.

Mechanism of Action

Leuprolide Acetate for Depot Suspension

Leuprolide acetate for depot suspension is a long-acting GnRH analog. A single injection of leuprolide acetate for depot suspension results in an initial elevation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing at quarterly intervals results in decreased secretion of gonadal steroids; consequently, tissues and functions that depend on gonadal steroids for their maintenance become quiescent. This effect is reversible on discontinuation of drug therapy.

Leuprolide acetate is not active when given orally.

Norethindrone Acetate

Norethindrone acetate induces secretory changes in an estrogen-primed endometrium.

Who should not take Lupaneta Pack?

Do not take Lupaneta Pack if you:

• have had an allergic reaction to medicines like leuprolide acetate for depot suspension or norethindrone acetate tablets. See the end of this guide for a complete list of ingredients in Lupaneta Pack.
• have uterine bleeding for which a cause has not been found
• are pregnant or may be pregnant. Lupaneta Pack may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Lupaneta Pack passes into your breast milk.
• had or have breast cancer or other cancers that are sensitive to hormones
• have problems with blood clots, a stroke or a heart attack.
• have liver problems

What should I tell my healthcare provider before taking Lupaneta Pack?

Before you take Lupaneta Pack, tell your doctor if you:

• drink alcohol
• smoke
• have a family history of bone loss (osteoporosis)
• have depression
• have high cholesterol
• have had blood clots, a stroke or a heart attack
• have migraine headaches
• have diabetes
• have epilepsy
• have kidney problems

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take anticonvulsant (seizure) or corticosteroid medicines.
Ask your doctor for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Lupaneta Pack?

• Leuprolide acetate for depot suspension for 3–month administration is injected into your muscle 1 time every 3 months by a healthcare professional in your doctor’s office.
• Take norethindrone acetate tablets exactly as your doctor tells you to take them. Take 1 norethindrone acetate tablet by mouth every day for 3 months after you receive your injection.
• Talk to your doctor about the birth control method that is right for you before you start taking Lupaneta Pack. You will need to use a form of birth control that does not contain hormones, such as:
  • a diaphragm with spermicide
  • condoms with spermicide
  • a copper IUD
• If you become pregnant while taking Lupaneta Pack, stop taking the norethindrone acetate tablets and call your doctor right away.

How well does Lupaneta Pack work?

Lupaneta Pack is used to treat pain due to endometriosis. The pain from endometriosis can happen when you have your period, during other times of the month, or during intercourse (sex). Most women feel some relief from their endometriosis pain after taking both drugs in Lupaneta Pack.

The tablets in Lupaneta Pack help lower the side effect of bone thinning that is caused by leuprolide acetate for depot suspension. Women taking both drugs in Lupaneta Pack lost an average of 1% of their bone density after about 1 year of treatment. Women regained some of their bone density about 1 year after they stopped treatment with Lupaneta Pack.

What are the possible side effects of Lupaneta Pack?

Lupaneta Pack may cause serious side effects, including:

• bone thinning (decreased bone mineral density)
• harm to your unborn baby
• vision problems. Call your doctor right away if you have sudden loss of vision, double vision, bulging eyes, or migraine headaches.
• depression or worsening depression
• allergic reactions. Get medical help right away if you have any of these symptoms of a serious allergic reaction:
  • swelling of your face, lips, mouth, or tongue
  • trouble breathing
  • wheezing
  • severe itching
  • skin rash, redness, or swelling
  • dizziness or fainting
  • fast heartbeat or pounding in your chest (tachycardia)
  • sweating
• worsening endometriosis symptoms when you start taking Lupaneta Pack
• swelling (fluid retention)

The most common side effects of Lupaneta Pack include:

• hot flashes and sweats
• headaches or migraine headaches
• depression and mood swings
• nausea and vomiting
• problems sleeping
• nervousness or feeling anxious
• pain
• acne
• weakness
• vaginal infection or inflammation
• weight gain
• constipation or diarrhea

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Lupaneta Pack. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Lupaneta Pack

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Lupaneta Pack for a condition for which it was not prescribed. Do not give Lupaneta Pack to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Lupaneta Pack. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Lupaneta Pack that is written for health professionals.

For more information, go to www.lupanetapack.com or call 1-800-633-9110.

How should I store Lupaneta Pack?

• Store norethindrone acetate tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Lupaneta Pack and all medicines out of the reach of children.

What are the ingredients in Lupaneta Pack?

Leuprolide acetate for depot suspension:

Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP

Norethindrone acetate tablets:

Active Ingredients: norethindrone acetate USP
Inactive Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc.

Label

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