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Libtayo

Generic name Cemiplimab: Rwlc [Se-MIPli-mab]
Drug class: monoclonal anti-PD-1 (immune-checkpoint inhibitors),

What is Libtayo?

Libtayo works with your immune system to treat skin tumours.Libtayo treats a type of cancer of the skin known as cutaneous squamous cell carcinoma that has spread or cannot be treated by radiation or surgery.Libtayo can be used to treat a form of skin cancer known as basal-cell carcinoma that is not able to be removed through surgery (locally advanced BCC) or has spread elsewhere in the body (metastatic BCC), if you have already received treatment with an HHI or cannot receive treatment.Libtayo can also be used to treat a lung cancer type called non-small cell lung cancer as a primary treatment when it has not spread beyond the chest area (locally advanced) and when you are unable to have radiation or chemotherapy, or if the cancer is metastatic and does not contain an abnormal "EGFR" "ALK", or "ROS1". It can be used with platinum-based chemotherapy or alone if your tumour tests high for "PDL1".Libtayo may cause your immune system to attack healthy organs and tissues in any part of your body and affect their function. Sometimes, these problems can become life-threatening or severe and even lead to death. These problems can occur at any time during or after treatment.

Warnings

Libtayo helps your body fight cancer by strengthening your immune system. The immune system may attack healthy organs or tissues. You may experience serious or even life-threatening health problems.Contact your doctor immediately if you experience any new or worsening symptoms, such as chest discomfort, coughing, breathing difficulties, swelling, nausea, or vomiting. Other symptoms include changes in weight or appetite, stomach pain, easy bleeding or bruising, severe weakness or mood changes, behavioural changes, severe fatigue, vision problems, and hair fall.

Similar/related drugs

Methotrexate (Keytruda), Lumakras methotrexate (Retevmo), Avastin, Keytruda and Retevmo

Before you take this drug

Tell your doctor if:

  • An immune system disorder, such as lupus or ulcerative colitis
  • A problem with the nervous system, such as Guillain-Barre syndrome or myasthenia graveis;
  • Radiation treatment for your chest area
  • An organ transplant.

Inform your doctor if a stem-cell transplant using donor cells has been performed or is planned.

Before starting Libtayo, you may need a negative pregnancy result.Cemiplimab can harm an unborn child. Prevent pregnancy by using effective birth control while taking this medication and for 4 months following your last dose. If you become pregnant, inform your doctor as soon as possible.Do not breastfeed while taking Libtayo or for 4 months following your last dose.

How to take Libtayo?

Libtayo can be infused into a vein. This injection will be given by a healthcare provider.The infusion should take no more than 30 minutes.The usual dosage of Libtayo for most people is once every three weeks, or until the body stops responding to it.Medical tests will be required frequently.

Details on dosage

Adult dose for squamous cell carcinoma:

If the disease progresses or toxicity is unacceptable, take 350 mg IV every 3 weeks.
Use: To treat patients with locally advanced or metastatic cutaneous squamous-cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiotherapy.

Adult dose for basal cell carcinoma:

If the disease progresses or there is unacceptable toxicity, then take 350 mg IV every 3 weeks.
Uses:
For locally advanced basal cell carcinomas (laBCC), previously treated with an inhibitor of the hedgehog pathway, or in whom an inhibitor of the hedgehog pathway is not appropriate
-For metastatic BCCs (mBCCs) that have been treated previously with a hedgehog pathway inhibitor or who are not suitable for a hedgehog pathway inhibitor

Adult dose for non-small cell lung cancer:

If the disease progresses or the toxicity is unacceptable, take 350 mg IV every 3 weeks.

Uses:
-in combination platinum-based chemotherapy as the first line treatment for adult patients with metastatic or locally advanced non-small-cell lung cancer (NSCLC) with no EGFR or ALK mutations.
-as a single agent in the first-line therapy of adult patients with metastatic or locally advanced NSCLC (in whom patients are not candidates to undergo definitive chemoradiation or surgical resection) whose tumours show high PD-L1 expression [Tumour proportion score (TPS = 50%)] as determined by FDA-approved tests and no EGFR or ALK aberrations.

What happens if I miss the dose?

If you are unable to attend your Libtayo appointment, call your doctor.

What happens if I overdose?

Overdoses are unlikely because this medicine is administered by a health professional in a medical environment.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Side effects of Libtayo

If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of your lips, face, tongue, or throat,If you experience a serious reaction to a drug, seek medical attention. This can include a fever, swollen lymph glands, muscle pains, weakness, unusual bruises, or yellowing, as well as bruising or burning of the eyes or skin, skin pains, and rashes with blisters or peeling.Some side effects can occur during injection. You should tell your carer if you experience any of the following symptoms: nausea, dizziness, lightheadedness, itching, tingling, or a rash.Cemiplimab RWLC helps your body fight cancer by strengthening your immune system. The immune system may attack healthy organs or tissues. You may experience serious or even life-threatening health problems.

If you experience:

  • Shortness of breath, new or worsening cough;
  • You may experience painful sores on your nose or in the genital region.
  • Fast or irregular heartbeats can cause chest pain.
  • Swollen glands;
  • Severe headaches, confusion, memory issues, hallucinations
  • Eye pain or redness (your eyes could be more sensitive to the light);
  • Symptoms include severe muscle weakness or pain, a stiff neck, and problems with balance.
  • Severe stomach pains, nausea, vomiting, and diarrhoea;
  • Unusual bruising
  • Transplant rejection: mouth sores or ulcers, nausea, feeling uneasy or sick, swelling or pain near the transplanted organ, or rash
  • Kidney disease: swelling of the ankles, bloody urine, or little or no urination.
  • Liver disorders: right-sided upper abdominal pain, drowsiness or bruising, dark urine or jaundice,
  • Signs of a hormonal condition: frequent or unusual headaches; dizziness; feeling very tired; mood or behaviour change; hoarse voice or deepened tone; increased thirst or hunger; increased urination or constipation; hair loss or thinning; sweating or feeling cold.

If you experience certain side effects, your cancer treatment may be delayed or discontinued permanently.

Common Libtayo adverse effects include:

  • Tiredness;
  • Hair loss;
  • You may experience numbness or pain in your feet or hands.
  • Muscle or bone pain
  • Rash;
  • Nausea, diarrhoea, and loss of appetite

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

Cemiplimab RWLC may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor of all the medicines you are taking, as well as any new ones.

 

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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