Planning for treatment: what to expect
Your healthcare provider will determine your dose, which may change over time.
IMCIVREE is given as an injection under the skin once per day in the morning.
As with many medicines, side effects are possible.
Understanding your dose
Your healthcare provider will determine the dose of IMCIVREE that’s right for you. Your dose will be measured in milligrams (mg) based on your age and response to treatment.
STARTING TREATMENT
When you first start treatment, you will have an initial dose called a starting dose.
For most people 12 years and older, this dose is 2 mg per day. For individuals between the ages of 6 and 12, this is typically 1 mg per day.
FIRST FEW WEEKS
Over the first few weeks of treatment, your healthcare provider will evaluate if your dose needs to change.
Your dose can be either increased or decreased depending on how you tolerate the medicine and respond to treatment. Like many new medicines, side effects can be expected. Your healthcare provider may adjust your dose to help manage initial side effects. This process of adjusting your dose is called titration.
ONGOING TREATMENT
Over time, you and your healthcare provider will continue to evaluate your response to treatment to determine if your dose needs any further adjustment.
Your healthcare provider may tell you to stop using IMCIVREE if you have not lost a certain amount of weight after 12 to 16 weeks of treatment.
Each vial of IMCIVREE contains enough medicine for more than one dose. The vial will include both medicine and air. Most of the vial will be filled with air. The number of doses in each vial will depend on your individual dose prescribed by your healthcare provider.
The table below shows the number of potential doses included in each vial based on different prescribed doses.
Storing your medicine
Store all vials of IMCIVREE, even those you have opened, in the original carton to protect them from light.
Store all vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
If needed, you can remove your vials from the refrigerator and store them at temperatures ranging from 36°F to 77°F (2°C to 25°C) for up to 30 days (but never past the expiration date). You can also briefly store them at up to 86°F (30°C). Vials you’ve stored at room temperature can be returned to the refrigerator.
Throw away any vials that:
- Are past their expiration date
- Have been stored at temperatures above 86°F (30°C)
- Have been out of the refrigerator for 30 days, even if it’s before their expiration date
- Have been opened for more than 30 days, even if some medicine is left in the vial
For full instructions on how to store your medicine, please review the Instructions for Use.
Learning to inject
Take IMCIVREE when you first wake up. It may be taken with or without food.
A healthcare provider will show you how to prepare and inject IMCIVREE before you inject for the first time; do not try to inject IMCIVREE unless you have been trained by a healthcare provider.
You can inject IMCIVREE on your own, or with the help of a caregiver.
Before injecting, you will need:
IMCIVREE vial
1 mL syringe with 28- or 29-gauge (28G or 29G) needle
2 alcohol wipes
Gauze pad
Sharps disposal container
Use only the syringes with needles provided to you with IMCIVREE. If you’re unsure if you have everything you need, be sure to review the IMCIVREE Instructions for Use.
IMCIVREE is injected directly under the skin, not into a vein or muscle.
You can inject IMCIVREE into your belly, the front of your thighs, or the back of your upper arms. When injecting into your belly, you can decide the exact spot, but it should be at least 2 inches away from your belly button:
- Avoid your belly button, ribs, and hip bones, as well as any scars or moles
- Never inject into an area that is red, swollen, or irritated
It's important to choose a different injection site each day – at least 1 inch away from the area you used for your previous injection.
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Side effects
IMCIVREE may cause serious side effects, including:
- Male and female sexual function problems. IMCIVREE can cause an erection that happens without any sexual activity in males (spontaneous penile erection) and unwanted sexual reactions (changes in sexual arousal that happen without any sexual activity) in females. If you have an erection lasting longer than 4 hours, get emergency medical help right away.
- Depression and suicidal thoughts or actions. You or a caregiver should call your healthcare provider right away if you have any new or worsening symptoms of depression.
- Increased skin pigmentation and darkening of skin lesions (moles or nevi) you already have. These changes happen due to how IMCIVREE works in the body and will go away when you stop using IMCIVREE. You should have a full body skin exam before starting and during treatment with IMCIVREE to check for skin changes.
- Benzyl alcohol toxicity. Benzyl alcohol is a preservative in IMCIVREE. Benzyl alcohol can cause serious side effects, including death, in premature and low-birth weight infants, who have received medicines that contain benzyl alcohol. IMCIVREE should not be used in premature and low-birth weight infants.
The most common side effects of IMCIVREE include:
- Darkening of the skin (hyperpigmentation)
- Injection site reactions
- Nausea
- Spontaneous erection
- Vomiting
- Diarrhea
- Headache
- Stretch marks
- Aggression
- Fatigue
These are not all the possible side effects of IMCIVREE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Rhythm Pharmaceuticals at 1-833-789-6337.
