Penpulimab-kcqx

Penpulimab is a prescription medication indicated for:

• metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in adults with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy
• in combination with gemcitabine plus cisplatin or carboplatin for first-line treatment of adults with recurrent or metastatic non-keratinizing NPC

Penpulimab is available under the following different brand names: Penpulimab-kcqx.

Common side effects of Penpulimab include:

• nausea
• vomiting
• decreased appetite
• decreased weight
• feeling tired
• rash
• low thyroid hormone levels
• constipation
• cough
• COVID-19 infection
• fever
• anemia

Serious side effects of Penpulimab include:

• lung problems may cause symptoms like cough, shortness of breath, chest pain
• intestinal problems may cause symptoms like diarrhea or more frequent bowel movements than usual, stools that are black, tarry, sticky, or have blood or mucus, severe abdominal pain or tenderness 
• liver problems may cause symptoms like yellowing of the skin or the whites of the eyes, dark urine, severe nausea or vomiting, bleeding or bruising more easily than normal, pain on the right side of the abdomen
• hormone gland problems may cause symptoms like unusual headaches, eye problems, sensitivity to light, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, voice getting deeper, dizziness or fainting, changes in mood or behavior, such as decreased sex drive, irritability or forgetfulness
• kidney problems may cause symptoms like reduced urine output, swelling of the ankles, blood in the urine, loss of appetite
• skin problems may cause symptoms like rash, itching, skin blistering or peeling, painful sores or ulcers in your mouth or nose, throat, or genital area, fever or flu-like symptoms, swollen lymph nodes
• symptoms of infusion reactions may include chills or shaking, dizziness, itching or rash, feeling like passing out, flushing, fever, shortness of breath or wheezing, and back pain
• risk of rejection of a transplanted organ or tissue
• complications, including graft-versus-host disease, in people who have received bone marrow transplant

Rare side effects of Penpulimab 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, coordination loss, 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

Injection solution

• 100 mg/10 mL (10 mg/mL) single-dose vial

Nasopharyngeal Carcinoma (NPC)

Adult dosage

• Single-agent therapy
  • 200 mg IV every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months
• Combination therapy
  • 200 mg IV every 3 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months, plus
  • Gemcitabine 1000 mg/m2 IV every 3 weeks for 6 cycles, and
  • Cisplatin 80 mg/m2 IV or carboplatin (AUC 5) IV every 3 weeks for 6 cycles

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. 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 Penpulimab?”

Long-Term Effects

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

Cautions

Immune-mediated adverse reactions

• May cause severe or fatal immune-mediated reactions
• May occur in any organ system or tissue and at any time after starting therapy, including after discontinuation
• For suspected reactions, initiate an appropriate workup to exclude alternative etiologies (e.g., infection)
• Institute medical management promptly; consult specialists as appropriate
• Hold or permanently discontinue based on severity
• Administer systemic corticosteroids (e.g., 1-2 mg/kg/day prednisone or equivalent) until improvement to grade 1 and lower, then taper corticosteroids over at least 1 month
• Other systemic immunosuppressants may be required if reactions are not controlled with corticosteroids

Immune-mediated pneumonitis

• Incidence of pneumonitis may be higher in patients with prior thoracic radiation

Immune-mediated colitis

• May present as diarrhea
• Cytomegalovirus infection/reactivation reported with corticosteroid-refractory immune-mediated colitis
• For corticosteroid-refractory colitis, consider repeating infectious workups to exclude alternative etiologies

Immune-mediated hepatitis

• Evaluate liver enzymes before initiating and periodically during therapy

Immune-mediated endocrinopathies

• Can cause immune-mediated adrenal insufficiency, thyroid disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism), and type 1 diabetes mellitus (which may present as diabetic ketoacidosis)
• Hypophysitis can cause hypopituitarism
• Hypothyroidism can follow hyperthyroidism
• Initiate symptomatic treatment (e.g., hormone replacement, insulin) as clinically indicated
• Evaluate thyroid function before initiation and periodically during therapy
• Monitor for hyperglycemia and other signs of diabetes

Immune-mediated nephritis

• May occur with renal dysfunction
• Evaluate renal function before initiation and periodically during therapy

Immune-mediated dermatologic reactions

• Bullous and exfoliative dermatitis may occur (e.g., SJS, TEN, DRESS)
• Treat mild to moderate non-exfoliative rashes with topical emollients and/or topical corticosteroids
• Hold or permanently discontinue depending on severity

Infusion-related reactions (IRR)

• May cause severe or life-threatening IRRs (e.g., hypersensitivity, anaphylaxis)
• Monitor for signs and symptoms of IRR
• Interrupt, reduce rate, or permanently discontinue based on severity

Complications of allogeneic hematopoietic stem cell transplantation (HSCT)

• Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody
• Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) 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
• Follow patients closely for evidence of transplant-related complications and intervene promptly
• Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCT

Embryo-fetal toxicity

• Fetal harm may occur if used during pregnancy
• Advise pregnant patients of the potential risk to the fetus
• Effective contraception is recommended during and after therapy in females of reproductive potential

Pregnancy and Lactation

• Fetal harm may occur if administered during pregnancy, based on the mechanism of action
• Fetal exposure may increase the risk of developing immune-mediated disorders or alter normal immune response
• No data available for pregnant patients
• Animal studies demonstrated that PD-1/PD-L1 pathway inhibition can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death
• Human IgG1 immunoglobulins are known to cross the placenta; therefore, transmission may potentially occur from mother to developing fetus
• Verify the pregnancy status of females of reproductive potential before starting treatment
• Advise pregnant patients of potential fetal risk

Contraception requirements

• Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose

Lactation

• No data available on presence in human milk or effects on breastfed children or milk production
• Maternal IgG is present in human milk; however, the effects of local gastrointestinal exposure and limited systemic exposure to penpulimab in breastfed children are unknown
• Due to the potential for adverse reactions in breastfed children, avoid breastfeeding during therapy and for 4 months after the last dose