Tremelimumab

Tremelimumab is a prescription medication used for the treatment of hepatocellular carcinoma and non-small cell lung cancer. 

• Tremelimumab is available under the following different brand names: Imjudo, and tremelimumab-actl.

Common side effects of Tremelimumab include:

• Rash,
• Diarrhea,
• Tiredness,
• Itching,
• Muscle or bone pain, and
• Stomach pain

Serious side effects of Tremelimumab include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Cough,
• Shortness of breath,
• Chest pain or pressure,
• Diarrhea,
• Stool that is black or tarries,
• Dark urine,
• Severe stomach pain,
• Severe nausea,
• Severe vomiting,
• Yellowing of your skin or eyes (jaundice),
• Unusual bleeding,
• Easy bruising,
• Increased sensitivity to light,
• Severe headaches,
• Fast or irregular heartbeats,
• Excessive sweating,
• Tiredness,
• Weight gain or loss,
• Increased appetite,
• Increased thirst,
• Increased urination,
• Hair loss,
• Feeling cold,
• Constipation,
• Hoarseness,
• Dizziness,
• Fainting,
• Decreased sex drive,
• Irritability,
• Problems with your memory,
• Little or no urination,
• Swelling in your feet or ankles,
• Loss of appetite,
• Rash,
• Itching,
• Skin that blisters or peels,
• Mouth sores,
• Skin sores,
• Fever,
• Flu-like symptoms,
• Swollen lymph nodes,
• Abdominal pain (upper right side),
• Confusion,
• Sleepiness,
• Changes in mood or behavior,
• Stiffness in your neck,
• Coordination or balance problems,
• Tingling or numbness of the arms or legs,
• Double vision,
• Blurry vision,
• Eye pain,
• Changes in the eyesight,
• Severe muscle pain,
• Weakness,
• Muscle cramps,
• Blow red blood cells,
• Chills,
• Shaking,
• Flushing,
• Wheezing, and
• Back or neck pain

Rare side effects of Tremelimumab include:

• None

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 20 mg/mL (1.25-mL, 15-mL single-dose vials)

Hepatocellular Carcinoma

Adult dosage

• Each cycle is 28 days.
• Cycle 1 in combination with durvalumab
• Weight above 30 kg: Tremelimumab 300 mg intravenous for 1 dose, THEN durvalumab 1500 mg intravenous
• Weight below 30 kg: Tremelimumab 4 mg/kg intravenous for 1 dose, THEN durvalumab 20 mg/kg intravenous
• Cycle 2 and thereafter
  • Weight above 30 kg: Durvalumab 1,500 mg intravenous every 4 weeks as a single agent
  • Weight below 30 kg: Durvalumab 20 mg/kg intravenous every 4 weeks as a single agent
  • Continue until disease progression or unacceptable toxicity.

Non-small Cell Lung Cancer

Adult dosage

• Weight-based dose above 30 kg.
• Tremelimumab 75 mg intravenous
• Durvalumab: 1500 mg intravenous
• Weight-based dose below 30 kg
• Tremelimumab 1 mg/kg intravenous
• Durvalumab: 20 mg/kg intravenous
• Cycles 1-4
  • Dose interval every 3 weeks
  • Administer Tremelimumab, durvalumab, and chemotherapy.
• Cycle 5 (week 12)
  • Starting at cycle 5, the dosing interval changes from every 3 weeks to every 4 weeks
  • Administer durvalumab and chemotherapy.
  • Note: If below 4 cycles of platinum-based chemotherapy are received, the remaining cycles of Tremelimumab (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with durvalumab, every 4 weeks
  • Optional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with no squamous disease who received treatment with pemetrexed and carboplatin/cisplatin
• Cycle 6 (week 16)
  • Administer Tremelimumab, durvalumab, and chemotherapy.
• Cycle 7 (week 20) and thereafter
  • Administer durvalumab and chemotherapy.
  • Continue durvalumab until disease progression or intolerable toxicity.
• Platinum-based chemotherapy regimens
  • Non-squamous NSCLC
    • Carboplatin plus nab-paclitaxel, OR
    • Carboplatin or cisplatin plus pemetrexed
  • Squamous NSCLC
    • Carboplatin plus nab-paclitaxel, OR
    • Carboplatin or cisplatin plus gemcitabine

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tremelimumab has severe interactions with no other drugs.
• Tremelimumab has serious interactions with no other drugs.
• Tremelimumab has moderate interactions with no other drugs.
• Tremelimumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tremelimumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tremelimumab?”

Cautions

• May cause an infusion-related reaction; monitor for signs and symptoms of infusion-related reactions; interrupt, slow the rate of, or permanently discontinue Tremelimumab; for Grade 1 or 2 infusion-related reactions, consider using premedication with subsequent doses
• Based on findings from animal studies and its mechanism of action, fetal harm may occur when administered to pregnant females
• Ocular side effects: May be associated with retinal detachment; various grades of visual impairment may occur; if events occur in combination with other immune-mediated adverse reactions, consider Vagt-Koyanagi-Harada-like syndrome; this may require treatment with systemic steroids to reduce the risk of permanent vision loss
• Severe or fatal immune-mediated adverse reactions
• Tremelimumab and durvalumab combined may potentiate the risk of immune-mediated adverse reactions.
• Severe or fatal immune-mediated adverse reactions may occur in any organ system or tissue at any time after starting both infusions.
• Immune-mediated adverse reactions may manifest during treatment and after discontinuation.
• Monitor for signs and symptoms of underlying immune-mediated adverse reactions.
• Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone level, and thyroid function at baseline and before each dose.
• Institute medical management promptly, including specialty consultation as appropriate.
• Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
• Immune-mediated adverse reactions include the following:
  • Colitis, pneumonitis, hepatitis, endocrinopathies (. g, adrenal sufficiency, hypophysitis, thyroiditis, hyperthyroidism, hypothyroidism, type 1 diabetes), nephritis with renal dysfunction, and/or dermatology reactions
  • Adrenal insufficiency: This may cause primary or secondary adrenal insufficiency.
  • Hypophysitis can present with acute symptoms associated with mass effect (. g, headache, photophobia, visual field cuts); hypophysitis can cause hypopituitarism.
  • Thyroiditis can present with or without endocrinopathy; initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
• May cause hyperthyroidism and/or hypothyroidism
  • Monitor for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.
  • Initiate symptomatic treatment including hormone replacement as clinically indicated.
  • Withhold or permanently discontinue Tremelimumab in combination with durvalumab based on the severity.
  • Immune-mediated pancreatitis may occur when administered in combination with durvalumab.
  • Other immune-mediated adverse reactions reported in less than 1% with durvalumab and tremelimumab combination and other immune-checkpoint inhibitors.
• Cardiac or vascular: Myocarditis, pericarditis, vasculitis
  • Nervous system: Meningitis, encephalitis, myelitis demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur
• Gastrointestinal: Gastritis, duodenitis
  • Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
• Endocrine: Hypoparathyroidism
  • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymph histiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, and immune thrombocytopenia

Pregnancy and Lactation

• Based on its mechanism of action, can cause fetal harm if administered to pregnant females
• No data are available on use in pregnant females.
• Verify the pregnancy status of females of reproductive potential before initiating treatment.
• Human immunoglobulin G1 (IgG1) is known to cross the placental barrier; therefore, Tremelimumab and durvalumab have the potential to be transmitted from the mother to the developing fetus.
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 3 months after the last dose.
  • Lactation
  • There are no data on the presence of Tremelimumab in human milk, its effects on a breastfed child, or milk production.
  • Maternal IgG is known to be present in human milk.
  • Effects of local gastrointestinal exposure and limited systemic exposure in breastfed children to Tremelimumab are unknown.
  • Advise females not to breastfeed during treatment and for 3 months after the last dose.