Details for: XYREM
Company: JAZZ PHARMACEUTICALS IRELAND LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02268272 | XYREM | SODIUM OXYBATE | 500 MG / ML | SOLUTION | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Xyrem is a brand of medicine used to reduce the number of cataplexy (weak or paralyzed muscles) attacks in patients with narcolepsy.
What it does
The mechanism by which Xyrem produces its anti-cataplectic effects is unknown.
When it should not be used
- take other sleep medicines or sedatives (medicines that cause sleepiness).
- have a rare condition called succinic semialdehyde dehydrogenase deficiency.
- are allergic to Xyrem or any of its ingredients.
Do not drink alcohol while you are taking Xyrem.
What the medicinal ingredient is
Sodium oxybate
What the non-medicinal ingredients are
Purified water and malic acid.
What dosage form it comes in
Oral solution containing 500 mg/mL sodium oxybate.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Xyrem. Talk about any health conditions or problems you may have, including if you:
- have had depression. You may be more likely to get depressed taking Xyrem.
- have liver problems. Your dose may need to be adjusted.
- have sleep apnea, snoring, or breathing or lung problems. You may be more likely to get serious side effects.
- are on a salt restricted diet, have high blood pressure, or heart failure. Xyrem contains significant levels of sodium (salt) and may not be right for you.
- are pregnant or plan to become pregnant or are breastfeeding. It is not known whether Xyrem can pass through your milk and harm the baby.
Tell your doctor or pharmacist about all the medicines you take, including prescription and non-prescription medicines, and natural health products.
Other warnings you should know about:
Do not drink alcohol or take sedatives. Alcohol and certain medicines can increase the chance of dangerous side effects.
Do not drive a car, operate heavy machinery, or perform any activity that requires mental alertness for at least 6 hours after taking Xyrem. When you first start taking Xyrem, use extreme care while undertaking similar activities the next day.
You should remain in bed after you have taken the first and second dose of Xyrem. Do not take the second dose until 2½ to 4 hours after the first dose. Xyrem can cause you to fall asleep quickly. Falling asleep while standing or while rising from the bed has led to falls and injuries which, in some cases, required hospitalization.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- alcohol or other sedative hypnotics
- antiepileptic drugs such al divalproex sodium (valproic acid)
Proper use of this medication
How to take Xyrem:
- It is important that you take Xyrem exactly as prescribed by your doctor.
- You and your physician will discuss your response to treatment including any side effects you may be experiencing, and your physician may adjust your dose as a result. Never change the dose of Xyrem yourself.
- Take Xyrem two times each night. Take the first dose right at bedtime and the second dose 2 ½ to 4 hours later. You may need to set an alarm to make sure you wake up to take the second dose
- You have to prepare the doses before you take them. You must mix each prescribed dose with 60 mL of water (2 ounces). See “How to Prepare and Take the Nightly Doses of Xyrem” for detailed instructions.
- Food will decrease the amount of Xyrem that your body absorbs. Make sure you eat your last meal at least 2 hours before you go to bed.
- Xyrem has a sedative effect and can make you sleepy. Stay in bed after you have taken the first and second doses of Xyrem.
Usual dose
- The starting dose is usually 4.5 grams total per night, divided in two equal doses of 2.25 grams each.
- Based on how you feel, your doctor may increase or decrease the dose every two weeks.
- The usual dose is between 6 grams to 9 grams in total per night.
- You can expect to see some improvement within the first weeks of Xyrem therapy. It may take up to 8 to 10 weeks to have the full benefits of Xyrem.
How to Prepare and Take the Nightly Doses of Xyrem:
CAUTION: Be very careful not to leave your Xyrem in a place where children or pets can get to it.
The Xyrem carton contains:
- 1 bottle of medicine
- printed product information
- 2 dosing cups with child-resistant caps
- 1 liquid measuring device (an oral syringe)
The measuring device is an oral syringe with markings only in grams. In case you need the dose in millilitres (mL), you can consult the conversion tables below:
| Single dose in grams (to be taken twice per night) |
Single dose in mL (to be taken twice per night) |
| 1.5 grams | 3 ml |
| 2.25grams | 4.5 ml |
| 3 grams | 6 ml |
| 3.75 grams | 7.5 ml |
| 4.5 grams | 9 ml |
| Total dose per night in grams | Total dose per night in mL |
| 3 grams | 6 ml |
| 3.5 grams | 9 ml |
| 6 grams | 12 ml |
| 7.5grams | 15 ml |
| 9 grams | 18 ml |
| Step 1 Remove the Xyrem bottle and the measuring device from the box (See Figure 1). |
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| Step 2 Remove the measuring device from the wrapper (See Figure 2). |
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| Step 3 Remove the bottle cap by pushing down while turning the cap counterclockwise (to the left). (See Figure 3). After removing the cap, set the bottle upright on a tabletop. |
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| Step 4 While holding the bottle in its upright position, insert the tip of the measuring device into the centre opening on top of the bottle and press down firmly (See Figure 4). |
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| Step 5 While holding the bottle and measuring device down with one hand, draw up the prescribed dose with the other hand by pulling on the plunger. Notes:
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| Step 6 Remove the measuring device from the centre opening of the bottle. Empty the medicine from the measuring device into one of the dosing cups provided by pushing on the plunger. Then add in approximately 60 mL or 2 ounces (oz) of water (or enough to fill ¾ of the cup). Repeat the process with the second dosing cup (See Figure 6). |
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| Step 6 (continued) Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position (See Figure 7). Recap the Xyrem bottle and store it in a safe and secure place (locked up if appropriate), out of the reach of children. Rinse out the liquid measuring device with water. |
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| Step 7 Right before going to sleep, place your second dose in a secure location (locked up if appropriate) near your bed. You may need to set an alarm so you wake up to take your second dose no earlier than 2 ½ hours and no later than 4 hours after your first dose. Remove the cap from the first dosing cup by pressing down on the child-resistant locking cap (See Figure 8) and turning the cap counterclockwise (to the left). Drink the entire first dose while sitting in bed, recap the cup, and then lie down right away (See Figure 9). |
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Overdose
- For the management of a suspected drug overdose, consult your regional Poison Control Centre.
- If you take more Xyrem than prescribed or take it by accident, seek medical help.
Missed Dose
If you miss the second dose, skip that dose and do not take Xyrem again until the next night. Never take two Xyrem doses at once.
Side effects and what to do about them
What are possible side effects from using Xyrem?
These are not all the possible side effects you may feel when taking Xyrem. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings you should know about.
- The most common side effects of Xyrem are headache, nausea, dizziness, sleep problems, confusion, vomiting, and some patients experience infrequent bed-wetting during the night. To help prevent bed-wetting, make sure you go to the bathroom before taking your first dose of Xyrem.
These are not all of the side effects of Xyrem. If you are concerned about any possible side effects consult your doctor or pharmacist.
Effects of abusing (misusing) Xyrem (GHB)
- GHB (gamma-hydroxybutyrate) can be a drug of abuse if used improperly, and some people who repeatedly abuse GHB become addicted to it. People who repeatedly abuse GHB at high frequency and at high doses can develop withdrawal symptoms. These symptoms include the need to continue taking the drug, anxiety, trouble sleeping, and abnormal thinking.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| COMMON | |||
| Increases sleepiness during the day | ✔ | ||
| UNCOMMON | |||
| Confusion | ✔ | ||
| Aggression | ✔ | ||
| Sleepwalking: walk while being asleep | ✔ | ||
| Depression | ✔ | ||
| Seizure | ✔ | ||
| Abnormal thinking | ✔ | ||
| Breathing problems | ✔ | ||
| Sleep apnea: stop breathing while you sleep | ✔ | ||
| UNKNOWN | |||
| Hallucination: seeing or hearing things that are not there | ✔ | ||
| Thoughts of killing yourself or trying to kill yourself | ✔ | ||
| Allergic reactions: red, itchy swellings on the skin, swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or breathing, rash or intense itching | ✔ | ||
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.
How to store
Always store Xyrem at room temperature (15°- 30°C), in the original bottle in a safe and secure place (locked up if appropriate), out of the reach of children and pets. Return any unused Xyrem to your pharmacy for proper disposal. Do not pour it down the drain. Always place your nightly doses of Xyrem safely out of the reach of children.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
What is the most important information I should know about Xyrem?
- The Xyrem Success Program, developed by the manufacturer of Xyrem, includes recommendations to doctors and pharmacists for educating patients on the safe and proper use of Xyrem. Through the Xyrem Success Program, educational materials will be provided to you by your doctor or pharmacist. Your doctor should confirm with you that you have read and understood these materials. During the course of Xyrem therapy, you should be seen by your doctor every 3 months, and an account of any side effects you may have experienced should be taken.
- Xyrem is available only by prescription and is a federally controlled drug. This means that it is illegal for you to sell, distribute, or give your Xyrem to anyone else, or for you to use your Xyrem for purposes other than for what it was prescribed.
- It is critical to keep Xyrem out of the reach of children.
- Xyrem may cause you to fall asleep quickly. Therefore, take Xyrem only at bedtime and while in bed. Do not drive a car, operate heavy machinery, or perform any activity that requires mental alertness for at least 6 hours after taking Xyrem, until you know whether it makes you sleepy the next day.
- The active ingredient in Xyrem is gamma-hydroxybutyrate (GHB), a chemical that has been abused (misused). Abuse can cause serious medical problems, including trouble breathing, seizures (convulsions), loss of consciousness, coma, and death. Abuse of Xyrem could also lead to dependence, craving for the medicine, and severe withdrawal symptoms.
If you want more information about Xyrem
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by calling 1-866-599-7365.
This leaflet was prepared by Jazz Pharmaceuticals Ireland Limited
Last Revised: June 11, 2018