Nemolizumab-Ilto (Subcutaneous Route)

Proper Use

Drug information provided by: Merative, Micromedex®

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.

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.