Description
Nemolizumab-ilto injection is used to treat prurigo nodularis (PN).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of nemolizumab-ilto injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nemolizumab-ilto injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Cyclosporine
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine, Live Non-Replicating
- Smallpox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Warfarin
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the thigh, stomach area, or upper arm. This medicine may also be given at home to patients who do not need to be in a hospital or clinic. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.
This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you use Nemluvio® at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are tender, bruised, red, or areas with scars or stretch marks.
Allow the medicine to warm to room temperature for 30 to 45 minutes before using it. Do not warm it using any heat source (eg, microwave, sunlight).
Do not use the pen if it is broken, cracked, or damaged, or if it has been dropped.
To use:
- Wash your hands with soap and water before and after using this medicine.
- Hold the pen upright and turn the activation knob to the right until it stops. Wait until the gray rod stops moving. When the gray rod has completely stopped, shake the pen up and down for 30 seconds.
- Wait for 5 minutes for the bubbles to decrease and the powder to dissolve completely.
- Check the liquid in the prefilled pen. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has particles in it.
- Hold the pen upright. Twist the gray cap until the orange needle guard appears. Gently pull the cap off.
- Place the pen vertically so that the orange needle guard is flat against the skin. Gently push the pen down until the orange needle guard is completely pushed in. Hold for 15 seconds. Check the inspection window to make sure the orange rod and gray rod have stopped.
- Lift the pen straight up from your skin. The orange needle guard locks into place to cover the needle.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (prefilled pen):
- For prurigo nodularis:
- Adults—Dose is based on body weight and must be determined by your doctor.
- Weighing 90 kilograms (kg) or more—At first, 60 milligrams (mg) (two 30 mg injections) injected under the skin, followed by 60 mg every 4 weeks.
- Weighing less than 90 kg—At first, 60 milligrams (mg) (two 30 mg injections) injected under the skin, followed by 30 mg every 4 weeks.
- Children—Use and dose must be determined by your doctor.
- Adults—Dose is based on body weight and must be determined by your doctor.
- For prurigo nodularis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Protect the medicine from direct light. Do not freeze or heat the pen. Keep the medicine in the original package until you are ready to use it. You may also store the prefilled pen at room temperature for up to 90 days. Throw away any unused pen that has been left at room temperature longer than 90 days.
Throw away or use the mixed solution within 4 hours after mixing.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reaction, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have dizziness, fainting, lightheadedness, fever, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, nausea or vomiting, skin rash, stomach cramps, or trouble breathing.
Do not have any live vaccines (immunizations) while you are being treated with nemolizumab-ilto. Check with your doctor before having any vaccines.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, scaly skin
- difficulty in breathing or swallowing
- fast heartbeat
- headache
- puffiness of the face
- skin itching, rash, or redness
- swelling of the face, throat, or tongue
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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