Libtayo

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

1. What is Libtayo used for?

Libtayo contains the active ingredient cemiplimab. Libtayo is an anti-cancer medicine. Libtayo is used in adults to treat types of skin cancer called advanced cutaneous squamous cell carcinoma (CSCC), and locally advanced or metastatic basal cell carcinoma (BCC), after previously receiving treatment with a hedgehog pathway inhibitor. Libtayo is also used in adults to treat advanced non-small cell lung cancer (NSCLC).

For more information, see Section 1. What is Libtayo used for? in the full CMI.

2. What should I know before I am given Libtayo?

Do not use if you have ever had an allergic reaction to Libtayo or any of the ingredients listed at the end of the CMI.

Check with your doctor if you have an autoimmune disease, have had an organ transplant, or you have received or plan to receive a bone marrow transplant using bone marrow from another person, or if you have lung or breathing problems, liver problems, kidney problems, diabetes, or any other medical conditions.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

If you are able to become pregnant, you must use an effective method of contraception to avoid becoming pregnant while you are being treated with Libtayo and for at least 4 months after the last dose.

Do not breast feed while you are being treated with Libtayo and for at least 4 months after the last dose.
For more information, see Section 2. What should I know before I am given Libtayo? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Libtayo and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Libtayo given?

Libtayo will be given to you under the supervision of a doctor experienced in cancer treatment.

Libtayo is given as a drip into a vein (intravenous infusion). The infusion will last about 30 minutes.

Libtayo is usually given every 3 weeks.

More instructions can be found in Section 4. How is Libtayo given? in the full CMI.

5. What should I know while using Libtayo?

Driving or using machines	Libtayo has no or minor influence on your ability to drive and use machines. If you feel tired, do not drive or use machines until you feel better.
Looking after your medicine	It is unlikely that you will be asked to store Libtayo yourself. It will usually be stored in the pharmacy or on the ward.

For more information, see Section 5. What should I know while using Libtayo? in the full CMI.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Libtayo.

Serious side effects can include skin problems, lung problems, liver problems, symptoms of type 1 diabetes, kidney problems, infusion-related reactions and problems in other parts of the body.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .

Active ingredient: cemiplimab

Consumer Medicine Information (CMI)

This leaflet provides important information about using Libtayo. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Libtayo.

It is important that you keep the Patient Alert Card with you during and after treatment.

Where to find information in this leaflet:

1. What is Libtayo used for?

2. What should I know before I am given Libtayo?

3. What if I am taking other medicines?

4. How is Libtayo given?

5. What should I know while using Libtayo?

6. Are there any side effects?

7. Product details

1. What is Libtayo used for?

Libtayo contains the active ingredient cemiplimab. Libtayo is an anti-cancer medicine.

Libtayo is used in adults to treat:

a type of skin cancer called advanced cutaneous squamous cell carcinoma (CSCC)

a type of skin cancer called advanced basal cell carcinoma (BCC) after previously receiving treatment with a hedgehog pathway inhibitor

a type of lung cancer called advanced non-small cell lung cancer (NSCLC).

Libtayo may be given in combination with chemotherapy for NSCLC. It is important that you also read the package leaflets for the specific chemotherapy you may be receiving. If you have any questions about these medicines, ask your doctor.

Libtayo works by helping your immune system fight your cancer.

2. What should I know before I am given Libtayo?

Warnings

You should not be given Libtayo if:

Libtayo works by helping your immune system fight your cancer.

If you think you may be allergic, or you are not sure, talk to your doctor before you are given Libtayo.

Some of the symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue, or other parts of the body

rash, itching or hives on the skin.

If you are not sure whether you should be given this medicine, talk to your doctor.

Check with your doctor if you:

you have an autoimmune disease (a condition where the body attacks its own cells)

you have had an organ transplant, or you have received or plan to receive a bone marrow transplant using bone marrow from another person (allogeneic hematopoietic stem cell transplant)

you have lung or breathing problems

you have liver problems

you have kidney problems

you have diabetes

you have any other medical conditions.

If you have not told your doctor about any of the above, tell him or her before you start taking Libtayo.

If any of the above apply to you, or you are not sure, talk to your doctor or nurse before you are given Libtayo.

Libtayo can cause some serious side effects that you need to tell your doctor about immediately. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one side effect at the same time. These serious side effects include:

Skin problems

Lung problems (pneumonitis)

Gut problems (colitis)

Liver problems (hepatitis)

Hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas

Type 1 diabetes

Kidney problems (nephritis and kidney failure)

Central nervous system problems (such as meningitis)

Muscle problems (inflammation of the muscles called myositis)

Infusion-related reactions

Problems in other parts of the body (see Side effects).

Look out for these side effects while you are receiving Libtayo. See additional information under Section 6. Are there any side effects? If you have any of these side effects, talk to your doctor immediately.

Your doctor may give you other medicines in order to stop more severe reactions and reduce your symptoms. Your doctor also may delay your next dose of Libtayo or stop your treatment.

Children and adolescents

Libtayo should not be used in children and adolescents below 18 years of age.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

Libtayo can harm your unborn baby.

Tell your doctor immediately if you become pregnant while you are being treated with Libtayo.

If you are able to become pregnant, you must use an effective method of contraception to avoid becoming pregnant:

while you are being treated with Libtayo and

for at least 4 months after the last dose.

Talk to your doctor about the contraception methods that you must use during this time.

Breastfeeding

If you are breast feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine.

Do not breast feed while you are being treated with Libtayo and for at least 4 months after the last dose.

It is not known if Libtayo passes into your breast milk.

3. What if I am taking other medicines?

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor, pharmacist or nurse if you are taking or have ever taken any of the following medicines:

a cancer medicine called idelalisib

medicines that make your immune system weak - examples include corticosteroids, such as prednisone. These medicines may interfere with the effect of Libtayo. However, once you are treated with Libtayo, your doctor may give you corticosteroids to reduce the side effects that you may have with Libtayo.

4. How is Libtayo given?

Libtayo will be given to you under the supervision of a doctor experienced in cancer treatment.

Libtayo is given as a drip into a vein (intravenous infusion).

The infusion will last about 30 minutes.

Libtayo is usually given every 3 weeks.

How much you will receive

The recommended dose of Libtayo is 350 mg.

Your doctor will decide how much Libtayo you will receive and how many treatments you will need.

Your doctor will test your blood for certain side effects during your treatment.

If you miss an appointment

Call your doctor as soon as possible to make another appointment.

It is very important that you do not miss a dose of this medicine.

If you stop receiving Libtayo

Do not stop treatment of Libtayo unless you have discussed this with your doctor.

This is because stopping your treatment may stop the effect of the medicine.

Patient Alert Card

The information in this Leaflet can be found in the Patient Alert Card you have been given by your doctor. It is important that you keep this Patient Alert Card and show it to your partner or caregivers.

If you have any questions about your treatment, ask your doctor.

5. What should I know while using Libtayo?

Driving and using machines

Libtayo has no or minor influence on your ability to drive and use machines.

If you feel tired, do not drive or use machines until you feel better.

Storage

It is unlikely that you will be asked to store Libtayo yourself. It will usually be stored in the pharmacy or on the ward.

Disposal

Do not store any unused portion of the infusion solution for re use.

Your doctor or nurse will dispose of any leftover Libtayo that is no longer needed.

6. Are there any side effects?

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Libtayo.

Libtayo may cause side effects that appear weeks or months after your last dose.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or nurse to answer any questions you may have.

Libtayo acts on your immune system and may cause inflammation in parts of your body. Inflammation may cause serious damage to your body and may need treatment or require you to stop treatment with Libtayo. Some inflammatory conditions may also lead to death.

Talk to your doctor before trying to treat any of your symptoms.

You may need periodic blood tests or other tests so that your doctor can check that your liver and kidneys are functioning as normal.

The following side effects have been reported in clinical trials of patients treated with cemiplimab alone and patients treated with cemiplimab in combination with chemotherapy.

Less serious side effects

Less serious side effects	What to do
Generalised signs and symptoms: Fatigue (feeling tired) Trouble sleeping Signs and symptoms of skin problems: rash, itching patches of thick, scaly or crusty skin Signs and symptoms of problems in other organ systems: Muscle or bone pain Diarrhoea Weak muscles Joint pain, swelling Inflammation of the mouth Eye redness, eye pain, blurred vision, light sensitivity High blood pressure Low red blood cells Low white blood cells (neutrophils)* Low platelets* Signs and symptoms of urinary tract infection: urge to urinate, urinating more often, or painful urination Hair loss	Speak to your doctors if you have any of these less serious side effects

Less serious side effects

What to do

Generalised signs and symptoms:

Fatigue (feeling tired)

Trouble sleeping

Signs and symptoms of skin problems:

rash, itching

patches of thick, scaly or crusty skin

Signs and symptoms of problems in other organ systems:

Muscle or bone pain

Diarrhoea

Weak muscles

Joint pain, swelling

Inflammation of the mouth

Eye redness, eye pain, blurred vision, light sensitivity

High blood pressure

Low red blood cells

Low white blood cells (neutrophils)*

Low platelets*

Signs and symptoms of urinary tract infection:

urge to urinate, urinating more often, or painful urination

Hair loss

Speak to your doctors if you have any of these less serious side effects

*Laboratory results - some side effects observed with Libtayo may not have symptoms and may only be discovered through blood tests.

Serious side effects

Serious side effects	What to do
Signs and symptoms of skin problems: widespread rash or itching skin blistering ulcers in mouth or other mucous membrane. Signs and symptoms of lung problems: shortness of breath chest pain new or worsening cough Signs and symptoms of problems with your intestines: frequent diarrhoea or more bowel movements than usual stools that are black or tarry or have blood and mucous severe stomach (abdomen) pain or tenderness Signs and symptoms of liver problems: severe nausea or vomiting feeling less hungry than usual pain on right side of your stomach yellowing of your skin or the whites of your eyes dark urine (the colour of tea) bleeding or bruising more easily than normal feeling sleepy Signs and symptoms of hormone gland problems (especially the thyroid, pituitary, and adrenal glands): headaches that will not go away or unusual headaches fast heartbeat increased sweating feeling more cold or hot than usual severe tiredness dizziness or fainting weight gain or weight loss feeling more hungry or thirsty than usual hair loss constipation your voice gets deeper very low blood pressure urinating more often than usual nausea or vomiting stomach (abdomen) pain changes in mood or behaviour (such as decreased sex drive, being irritable or forgetful) Signs and symptoms of blood sugar problems or diabetic ketoacidosis: feeling more hungry or thirsty than usual needing to urinate more often weight loss feeling tired or sick stomach pain fast and deep breathing confusion unusual sleepiness a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat Signs and symptoms of kidney problems: change in the amount or colour of your urine blood in your urine swollen ankles feeling less hungry than normal. Signs and symptoms of infusion (IV) reactions: shortness of breath or wheezing chills, shaking or fever itching or rash flushing or swollen face dizziness nausea, vomiting or abdominal pain. Signs and symptoms of problems in other organ systems: Nervous system problems headache or stiff neck fever or chills feeling tired or weak vomiting confusion, memory problems or feeling sleepy fits (seizures) seeing or hearing things that are not really there (hallucinations) severe muscle weakness tingling, numbness weakness or burning pain in arms or legs paralysis in the extremities Muscle and joint problems joint pain or swelling muscle pain or weakness which could be associated with a rash (dermatomyositis) or stiffness Eye problems Eye problems changes in eyesight eye pain or redness sensitivity to light Heart and circulatory problems changes in heartbeat, heart beating fast, seeming to skip a beat or pounding sensation chest pain shortness of breath Blood problems fever or chills fast heartbeat chest pain shortness of breath pale skin, or yellowing of the skin and whites of the eyes weakness and fatigue fainting dark urine a feeling of abdominal fullness Other: dryness in many parts of the body from mouth to eyes, nose, throat and the top layers of skin bruises on the skin or bleeding, enlarged liver and/or spleen, lymph node enlargement There are possible side effects of treatment with Libtayo in people who have received a transplant: Rejection of a transplanted organ rejection has been reported with PD-1 inhibitors. Your doctor should tell you what signs and symptoms you should report, depending on the type of organ transplant you had	If any of the following happen after you have been given Libtayo tell your doctor immediately. If you cannot reach your doctor you must seek immediate medical attention

Serious side effects

What to do

Signs and symptoms of skin problems:

widespread rash or itching

skin blistering

ulcers in mouth or other mucous membrane.

Signs and symptoms of lung problems:

shortness of breath

chest pain

new or worsening cough

Signs and symptoms of problems with your intestines:

frequent diarrhoea or more bowel movements than usual

stools that are black or tarry or have blood and mucous

severe stomach (abdomen) pain or tenderness

Signs and symptoms of liver problems:

severe nausea or vomiting

feeling less hungry than usual

pain on right side of your stomach

yellowing of your skin or the whites of your eyes

dark urine (the colour of tea)

bleeding or bruising more easily than normal

feeling sleepy

Signs and symptoms of hormone gland problems (especially the thyroid, pituitary, and adrenal glands):

headaches that will not go away or unusual headaches

fast heartbeat

increased sweating

feeling more cold or hot than usual

severe tiredness

dizziness or fainting

weight gain or weight loss

feeling more hungry or thirsty than usual

hair loss

constipation

your voice gets deeper

very low blood pressure

urinating more often than usual

nausea or vomiting

stomach (abdomen) pain

changes in mood or behaviour (such as decreased sex drive, being irritable or forgetful)

Signs and symptoms of blood sugar problems or diabetic ketoacidosis:

feeling more hungry or thirsty than usual

needing to urinate more often

weight loss

feeling tired or sick

stomach pain

fast and deep breathing

confusion

unusual sleepiness

a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat

Signs and symptoms of kidney problems:

change in the amount or colour of your urine

blood in your urine

swollen ankles

feeling less hungry than normal.

Signs and symptoms of infusion (IV) reactions:

shortness of breath or wheezing

chills, shaking or fever

itching or rash

flushing or swollen face

dizziness

nausea, vomiting or abdominal pain.

Signs and symptoms of problems in other organ systems:

Nervous system problems

headache or stiff neck

fever or chills

feeling tired or weak

vomiting

confusion, memory problems or feeling sleepy

fits (seizures)

seeing or hearing things that are not really there (hallucinations)

severe muscle weakness

tingling, numbness

weakness or burning pain in arms or legs

paralysis in the extremities

Muscle and joint problems

joint pain or swelling

muscle pain or weakness which could be associated with a rash (dermatomyositis) or stiffness

Eye problems

Eye problems

changes in eyesight

eye pain or redness

sensitivity to light

Heart and circulatory problems

changes in heartbeat, heart beating fast, seeming to skip a beat or pounding sensation

chest pain

shortness of breath

Blood problems

fever or chills

fast heartbeat

chest pain

shortness of breath

pale skin, or yellowing of the skin and whites of the eyes

weakness and fatigue

fainting

dark urine

a feeling of abdominal fullness

Other:

dryness in many parts of the body from mouth to eyes, nose, throat and the top layers of skin

bruises on the skin or bleeding, enlarged liver and/or spleen, lymph node enlargement

There are possible side effects of treatment with Libtayo in people who have received a transplant:

Rejection of a transplanted organ

rejection has been reported with PD-1 inhibitors. Your doctor should tell you what signs and symptoms you should report, depending on the type of organ transplant you had

If any of the following happen after you have been given Libtayo tell your doctor immediately. If you cannot reach your doctor you must seek immediate medical attention

The above list includes serious side effects that may require urgent medical attention or hospitalisation.

These are not all of the possible side effects of Libtayo. Call your doctor for advice about side effects.

Other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything else that is making you feel unwell.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is only available with a doctor's prescription.

What Libtayo contains

Active ingredient (main ingredient)	One ml of concentrate contains 50 mg of cemiplimab. Each vial contains 350 mg cemiplimab in 7 ml of concentrate.
Other ingredients (inactive ingredients)	Histidine Histidine monohydrochloride monohydrate Proline Sucrose Polysorbate 80 Water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What Libtayo looks like

Libtayo concentrate for solution for infusion (sterile concentrate) is supplied as a clear to slightly opalescent, colourless to pale yellow sterile solution that may contain trace amounts of translucent to white particles.

Each carton contains 1 glass vial with 7 ml of concentrate.

LIBTAYO cemiplimab 350 mg concentrate for solution for infusion AUST R 320609