Patient Medication Information: uses, side effects, how to take - Jamp Elagolix
What is JAMP Elagolix used for?
- JAMP Elagolix is used to treat the painful symptoms of endometriosis.
- Endometriosis happens when the tissue that forms the lining of the womb grows in other parts of the body. This can cause pain when you have your period, during other times of the month or during sex.
It is not known if JAMP Elagolix is safe and effective in children under 18 years old.
How does JAMP Elagolix work?
Estrogen is the hormone that causes the tissues lining your womb to thicken each month. When estrogen levels go down, the tissues break down and you get your period. When this happens to tissues growing outside of your womb, you can bleed inside your body. This causes pain and scars to form.
JAMP Elagolix treats endometriosis by lowering the amount of estrogen in your body. The symptoms of endometriosis often get better after 1 month of taking JAMP Elagolix.
JAMP Elagolix improves the symptoms of endometriosis, such as:
- pain during periods
- pain between periods
- heavy bleeding during periods
- pain during sex
- pain or discomfort in the belly or pelvic region
Patients who take JAMP Elagolix are often able to stop taking other kinds of pain medications for endometriosis. Talk to your healthcare professional to see if this is an option for you.
JAMP Elagolix may help you feel better by reducing your pain. It may also improve your emotional well-being, and help you feel like you have more control over your symptoms.
What are the ingredients in JAMP Elagolix?
Medicinal ingredient: elagolix (as elagolix sodium)
Non-medicinal ingredients: calcium carboxymethyl cellulose, colloidal silicon dioxide, crospovidone, mannitol, poloxamer, polyethylene glycol, polyvinyl alcohol, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide
The 150 mg tablet also contains carmine.
The 200 mg tablet also contains iron oxide red.
JAMP Elagolix comes in the following dosage forms:
Tablets: 150 mg and 200 mg elagolix (as elagolix sodium)
Do not use JAMP Elagolix if:
- you are allergic to elagolix or to any of the other ingredients in JAMP Elagolix
you are pregnant or think you might be pregnant.
- you have severe liver disease.
- you know you have osteoporosis.
- you have unexplained bleeding from your vagina.
- you are taking cyclosporine, used to prevent organ rejection in people who have had organ transplants, or gemfibrozil, used to lower high cholesterol.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Elagolix. Talk about any health conditions or problems you may have, including if you:
have a history of bone mineral loss. JAMP Elagolix may result in a small loss of minerals from bone. The bone mineral loss may be increased during treatment with JAMP Elagolix if you:
- use alcohol excessively.
- smoke.
- have a family history of osteoporosis (thinning of the bones with fractures).
- take other medications that can cause thinning of the bones, for example steroids.
- have liver problems.
- have a history of mental health problems such as depression or suicidal thoughts.
- are pregnant or trying to get pregnant. You should not become pregnant while taking JAMP Elagolix. JAMP Elagolix may affect the way your unborn baby develops or cause early pregnancy loss (miscarriage). If you think you have become pregnant while taking JAMP Elagolix, stop taking JAMP Elagolix and contact your healthcare professional immediately.
- are breastfeeding or plan to breastfeed. The effects of JAMP Elagolix on breast milk and the nursing baby are not known. Talk to your healthcare professional about the best way to feed your baby if you take JAMP Elagolix.
Other warnings you should know about:
Birth control: JAMP Elagolix is NOT birth control. JAMP Elagolix does not prevent pregnancy. You will need to use effective methods of birth control while taking JAMP Elagolix. Talk to your healthcare professional about which birth control to use while taking JAMP Elagolix. Your healthcare professional may change your birth control when you start treatment with JAMP Elagolix as hormonal birth control that contains estrogen can affect how JAMP Elagolix works. You must continue to use effective birth control for 1 week after stopping treatment with JAMP Elagolix.
Bleeding changes: JAMP Elagolix may change your periods. This may lead to:
- irregular bleeding or spotting
- increase or decrease in bleeding
- no bleeding at all
These changes may make it harder to know if you are pregnant. Periods generally come back about 4 weeks after stopping JAMP Elagolix.
Bone health: Taking JAMP Elagolix can result in a small loss of minerals from your bones. If you use JAMP Elagolix for a long time, it may increase the risk of weak, porous bones (osteoporosis). This could increase the risk of broken bones, especially after menopause. Your bones may not recover completely when you stop taking JAMP Elagolix. While you are taking JAMP Elagolix, your healthcare professional may tell you to:
- exercise regularly
- eat a healthy diet
- take vitamin D, calcium supplements
Your healthcare professional may order an X-ray test after 1 year of use of JAMP Elagolix or more often, if needed. This test, called DXA, is used to check your bone health.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following medicines may interact with JAMP Elagolix:
- digoxin, which is used to treat some heart conditions
- rifampin, which is used to treat certain infections
- midazolam, which is used to treat anxiety
- rosuvastatin, which is used to lower blood cholesterol
- omeprazole, which is used to treat heartburn and stomach ulcers
- hormonal birth control that contains estrogen, such as “the pill”
How to take JAMP Elagolix:
Before you start taking JAMP Elagolix, be sure you understand what it is and how to take it. Take JAMP Elagolix as directed by your doctor. If you have questions about JAMP Elagolix, ask your healthcare professional.
Take JAMP Elagolix at about the same time each day. You may take JAMP Elagolix with or without food.
You should start taking JAMP Elagolix during your period to ensure you are not pregnant. You must confirm that you are not pregnant before starting treatment with JAMP Elagolix.
Usual dose:
Your healthcare professional may prescribe either:
- JAMP Elagolix 150 mg (a light pink tablet) once a day
- JAMP Elagolix 200 mg (a light orange tablet) twice a day
Overdose:
| If you think you, or a person you are caring for, have taken too much JAMP Elagolix, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
150 mg once a day: take it as soon as you remember, as long as it is on the same day. Do not take more than 1 tablet each day.
200 mg twice a day: take it as soon as you remember, as long as it is on the same day. Do not take more than 2 tablets each day.
What are possible side effects from using JAMP Elagolix?
These are not all the possible side effects you may feel when taking JAMP Elagolix. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- hot flash
- night sweats
- headache
- dizziness
- feeling sick to the stomach (nausea)
- diarrhea, stomach pain, constipation
- weight increase
- difficulty sleeping
- anxiety, depression, irritability
- mood swing
- decreased sex drive (libido)
- runny, stuffy nose, sore throat, sinus infection, common cold
- joint pain
menstrual bleeding changes:
- irregular bleeding or spotting
- increase or decrease in bleeding
- no bleeding at all
JAMP Elagolix can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
Mood Changes: feeling sad or depressed, being tearful, loss of interest in daily activities, thoughts of harming yourself (suicidal thoughts) | ✓ | ||
| VERY RARE | |||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
| FREQUENCY UNKNOWN (reported from postmarketing) | |||
Allergic Reaction / Angioedema: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue, or throat | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store between 2-30°C.
Keep out of reach and sight of children.
If you want more information about JAMP Elagolix:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091.
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
