Dostarlimab

Dostarlimab is a prescription medication indicated for:

• Endometrial cancer 
  • in combination with carboplatin and paclitaxel for primary advanced or recurrent endometrial cancer
  • as a single agent for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following before treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation
• Adults with dMMR recurrent or advanced solid tumors who have progressed on or following previous treatment and have no satisfactory therapeutic options
• Dostarlimab is available under the following different brand names: Jemperli, dostarlimab-gxly

Common side effects of Dostarlimab include:

• fatigue,
• weakness,
• nausea,
• diarrhea,
• anemia,
• constipation,
• vomiting,
• urinary tract infection (UTI),
• decreased appetite,
• muscle pain,
• cough, and
• itching

Serious side effects of Dostarlimab include:

• new or worsening cough, shortness of breath,
• chest pain, irregular heartbeats,
• a light-headed feeling,
• a seizure,
• confusion, hallucinations, eye pain or redness, vision problems,
• severe stomach pain, nausea, vomiting, diarrhea, bloody or tarry stools,
• low red blood cells (anemia)--pale skin, tiredness, cold hands and feet,
• kidney problems--swelling in your ankles, blood in your urine, little or no urination,
• liver problems--right-sided upper stomach pain, loss of appetite, bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a hormonal disorder--frequent or unusual headaches, dizziness, feeling very weak, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain or loss.

Rare side effects of Dostarlimab 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

• 50 mg/mL (10 mL, single-dose vials)

Mismatch Repair–Deficient (dMMR) Tumors

Adult dosage

• Doses 1-4: 500 mg IV every 3 weeks, THEN
• Dose 5 and thereafter (start 3 weeks after Dose 4): 1,000 mg IV every 6 weeks until disease progression or unacceptable toxicity

Endometrial Cancer

Adult dosage

• Single agent
  • 500 mg IV over 30 min every 3 weeks for 4 cycles, THEN
  • 1,000 mg IV every 6 weeks
  • Continue until disease progression or unacceptable toxicity
• Combination therapy
  • Dostarlimab 500 mg IV over 30 min on Day 1, PLUS
  • Carboplatin AUC 5 IV on Day 1, PLUS
  • Paclitaxel 175 mg/m2 IV on Day 1  
  • Every 3 weeks for 6 cycles, THEN
  • Dostarlimab 1,000 mg monotherapy IV every 6 weeks
  • Continue until disease progression, unacceptable toxicity, or up to 3 years

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.

• Dostarlimab has severe interactions with no other  drugs:
• Dostarlimab has serious interactions with no other drugs.
• Dostarlimab has moderate interactions with no other drugs.
• Dostarlimab 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, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• May cause severe or life-threatening infusion-related reactions; monitor for signs and symptoms of infusion-related reactions
• Severe infections (eg, sepsis, herpes encephalitis, mycobacterial infection) leading to retroperitoneal hemorrhage reported; most common infection was upper respiratory tract infection; monitor for signs and symptoms of infection
• Can cause fetal harm
• Immune-mediated adverse reactions
  • Severe or fatal immune-mediated adverse reactions can occur in any organ system or tissue
  • May start at any time after initiating a programmed death 1 (PD-1)/programmed death-ligand 1 (PD-L1)–blocking antibody; may manifest during treatment and after discontinuation
  • Immune-mediated pneumonitis, colitis, hepatitis, hypophysitis, thyroid disorders, thyroiditis, hypothyroidism, nephritis, or hyperthyroidism may occur
• Can cause primary or secondary adrenal insufficiency
  • Type 1 diabetes mellitus reported, which can present with diabetic ketoacidosis; monitor for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated; withhold or permanently discontinue depending on the severity
  • Immune-mediated rash or dermatitis (bullous and exfoliative dermatitis, SJS, TEN, DRESS syndrome) has occurred
  • Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions
  • If immune-mediated adverse reactions are suspected, initiate appropriate workup to exclude alternative etiologies, including infection; institute medical management promptly, including specialty consultation as appropriate
• Other immune-mediated adverse reactions are the following
  • Nervous system: Meningitis, encephalitis, myelitis, myasthenic syndrome/myasthenia gravis, Guillain Barre syndrome, nerve paresis, autoimmune neuropathy
  • Cardiac/vascular: Myocarditis, pericarditis, vasculitis
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities; some cases can be associated with retinal detachment; various grades of visual impairment including blindness can occur; if uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi–Harada like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
• Gastrointestinal: Pancreatitis, including increases in serum amylase and lipase levels, gastritis, duodenitis
  • Musculoskeletal and connective tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
• Endocrine: Hypoparathyroidism
  • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection
  • Complications of allogeneic hematopoietic stem cell transplantation
  • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody
  • Transplantation-related complications include hyperacute graft versus host disease (GVHD), acute GVHD, chronic GVHD, the hepatic veno-occlusive disease after reduced-intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
  • These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT
  • Closely monitor for evidence of transplantation-related complications and intervene promptly; consider benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCT

Pregnancy and Lactation

• Based on its mechanism of action, can cause fetal harm when administered during pregnancy
• No available data on use in pregnant females
• Verify pregnancy status in females of reproductive potential before initiation
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for at least 4 months following the last dose
• Lactation
  • No data are available on presence in human milk, its effects on breastfed children, or milk production
  • Advise lactating females not to breastfeed during treatment and for at least 4 months after the last dose