Libtayo

Libtayo is a prescription medication used to treat metastatic cutaneous squamous cell carcinoma (CSCC).

Libtayo belongs to a group of drugs called monoclonal antibodies. It works by blocking a protein called PD-1 on certain immune cells called T-cells. This protein helps cancer cells avoid being found and destroyed by the body’s immune system. Blocking the PD-1 protein helps the immune system recognize the cancer cells and attack them. 

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Libtayo include tiredness, rash, and diarrhea.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

It is not known if Libtayo is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Libtayo. See the “Libtayo Precautions” section.

Common side effects of Libtayo include the following:

• Tiredness
• Rash
• Diarrhea

This is not a complete list of Libtayo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Libtayo.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include:

• new or worsening cough
• shortness of breath
• chest pain

Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems (hepatitis). Signs and symptoms of hepatitis may include:

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• drowsiness
• dark urine (tea colored)
• bleeding or bruising more easily than normal
• feeling less hungry than usual

Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:

• headache that will not go away or unusual headaches
• rapid heart beat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• dizziness or fainting
• feeling more hungry or thirsty than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• very low blood pressure
• urinating more often than usual
• nausea or vomiting
• stomach-area (abdomen) pain
• changes in mood or behavior, such as decreased sex drive, irritability or forgetfulness

Kidney problems, including nephritis and kidney failure. Signs of these problems may include:

• drowsiness
• dark urine (tea colored)
• swelling in your ankles
• loss of appetite

Skin problems. Signs of these problems may include:

• rash
• itching
• skin blistering
• painful sores or ulcers in mouth or nose, throat, or genital area

Problems in other organs. Signs of these problems may include:

• headache
• tiredness or weakness
• sleepiness
• changes in heartbeat, such as beating fast, or seeming to skip a beat, or pounding sensation
• confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis)
• swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis)
• seeing or hearing things that are not there (hallucinations) severe muscle weakness
• low red blood cells (anemia)
• bruises on the skin or bleeding
• changes in eyesight

Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had. Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• fever
• feel like passing out back or neck pain facial swelling

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with Libtayo if you have severe side effects.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Libtayo, there are no specific foods that you must exclude from your diet when receiving Libtayo.

Before taking Libtayo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Libtayo or to any of its ingredients
• Have kidney problems
• Have liver problems
• Have immune system problems such as Crohn's disease, ulcerative colitis, or lupus
• Have had an organ transplant
• Have lung or breathing problems
• Have diabetes
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Libtayo can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will give you a pregnancy test before you start treatment with Libtayo.
• You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of Libtayo. Talk to your healthcare provider about birth control methods that you can use during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.

Your healthcare provider will give you Libtayo into your vein through an intravenous (IV) line over 30 minutes.

• Libtayo is usually given every 3 weeks.
• Your healthcare provider will decide how many treatments you will need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

The recommended dosage of Libtayo is 350 mg infused intravenously over 30 minutes every 3 weeks. Follow your doctor's instructions about your individual dosing schedule. It is important to keep all of your appointments to receive your Libtayo dose.

If you experience unacceptable toxicity or side effects become intolerable, you may need to wait longer between dose or permanently stop the medicine.

This medication is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Keep all of your scheduled appointments. If you have to miss a scheduled dose, contact your healthcare provider to reschedule as soon as possible.