Palarccio

Palarccio is a medicine used to treat advanced kidney cancer, either alone or with other medicines, by blocking proteins that help cancer cells grow and get blood supply.

Form
kapseli, kova
Strength
4 mg
Active Ingredient
Lenvatinib besilate
Manufacturer
Sandoz A/S

How to Use

Dosage

Typical daily dose is 20 mg (two 10 mg capsules) with pembrolizumab, or 18 mg (one 10 mg and two 4 mg capsules) with everolimus. If you have severe liver or kidney problems, the recommended dose is 10 mg (one 10 mg capsule) with everolimus.

Method

Take capsules whole with water, with or without food, around the same time each day. Do not open capsules.

Important

The maximum daily dose is usually 20 mg or 18 mg, depending on the combination therapy. Your doctor may adjust your dose based on side effects.

Possible Side Effects

COMMON
  • Low blood platelet count (can lead to bruises and slow wound healing)
  • Low white blood cell count
  • Underactive thyroid (symptoms include tiredness, weight gain, constipation, feeling cold, dry skin, and changes in thyroid blood tests)
  • Changes in blood tests for potassium and calcium (low levels)
  • Changes in blood tests for magnesium (low level) and cholesterol (high level)
  • Loss of appetite or weight loss
  • Trouble sleeping
  • Dizziness
  • Headache
  • Bleeding (most often nosebleeds, but also in urine, bruises, gums, or intestinal wall)
  • High or low blood pressure
  • Hoarseness
  • Nausea, vomiting, constipation, diarrhea, stomach pain, or digestive problems
  • Dry, sore, or inflamed mouth, or a strange taste in your mouth
  • High levels of lipase and amylase (digestive enzymes) in blood tests
  • Changes in liver function blood tests
  • Redness, soreness, and swelling on the skin of your hands and feet (palmoplantar erythrodysesthesia)
  • Rash
  • Back pain
  • Joint or muscle pain
  • High protein in urine tests and urinary tract infections (more frequent and painful urination)
  • Changes in kidney function blood tests and kidney failure
  • Severe tiredness or weakness
  • Swelling in the legs
  • Dehydration (loss of body fluids)
  • Heart palpitations (fast or irregular heartbeat)
  • Anal fistula (a small channel between the anus and surrounding skin)
  • Abdominal swelling or gas
  • Liver failure (symptoms may include drowsiness, confusion, poor concentration, or loss of consciousness)
  • Gallbladder inflammation
  • Dry, thickened, and itchy skin
  • Feeling unwell
RARE
  • Painful infection or irritation near the anus
  • Severe upper abdominal pain, possibly with fever, chills, nausea, and vomiting (spleen infarction)
  • Mini-stroke (transient ischemic attack)
  • Severe breathing difficulties and chest pain caused by air leaking from the lungs into the chest (preventing lungs from filling with air)
  • Inflammation of the pancreas (pancreatitis)
  • Inflammation of the large intestine (colitis)
  • Liver damage
  • Jaw bone damage (osteonecrosis)
  • Wound healing problems
  • Reduced hormone production by the adrenal glands
  • Tumor Lysis Syndrome (TLS)
  • Enlargement or weakening of a blood vessel wall, or a tear in a blood vessel wall (aneurysms and arterial dissections)
  • Other types of fistulas (abnormal connections between different organs in the body or from an organ to the skin, such as to the throat and windpipe). Symptoms depend on where the fistula is located.
  • A hole (perforation) in the stomach or intestine

Important Warnings

  • Do not take Palarccio if you are allergic to lenvatinib or any other ingredient in this medicine.
  • Do not breastfeed while taking Palarccio, as the medicine can harm your baby.
  • Use effective birth control during treatment and for at least one month after. Do not plan to get pregnant during treatment, and tell your doctor right away if you become pregnant.
  • Talk to your doctor before taking Palarccio if you have high blood pressure, heart problems, or have had a stroke.
  • Talk to your doctor if you have liver or kidney problems.
Show 12 more warnings
  • Tell your doctor if you recently had surgery or radiation, or if you need major surgery, as Palarccio can affect wound healing.
  • Talk to your doctor if you are over 75 years old, weigh less than 60 kg, or are not of Caucasian or Asian ethnic origin.
  • Tell your doctor if you have had abnormal connections between organs (fistulas) or problems with blood vessels like aneurysms (weakened vessel walls) or vessel tears.
  • Report any mouth pain, jaw issues, or loose teeth to your doctor, especially if you are taking medicines for osteoporosis or other cancer treatments that affect blood vessels, as Palarccio can cause jaw bone damage.
  • Watch out for Tumor Lysis Syndrome (TLS): symptoms like nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, or tiredness could be serious. Tell your doctor right away.
  • Seek urgent medical help if you have numbness or weakness on one side, severe headache, seizures, confusion, speech or vision changes, or dizziness, as these could be signs of a stroke or bleeding in the brain.
  • Seek urgent medical help if you have chest pain or pressure, pain in your arms, back, neck, or jaw, shortness of breath, a fast or irregular heartbeat, coughing, blue lips or fingers, or extreme tiredness, as these could be signs of heart problems or blood clots in your lungs.
  • Seek urgent medical help if you have severe stomach pain, as this could be a sign of a hole in the bowel or a fistula (abnormal connection).
  • Seek urgent medical help if you have black, tarry, or bloody stools, or cough up blood, as these could be signs of internal bleeding.
  • Seek urgent medical help if you have severe diarrhea, nausea, or vomiting, as this can lead to dehydration and kidney problems.
  • Palarccio is not recommended for children and adolescents under 18 years of age.
  • This medicine can make you feel dizzy or tired. Do not drive or use machines if you experience these effects.