Teplizumab

Teplizumab is a prescription medication used for the treatment of type 1 diabetes mellitus.

• Teplizumab is available under the following different brand names: teplizumab-mzwv, Tzield

Common side effects of Teplizumab include:

• rash,
• decreased white blood cell count, and
• headache

Serious side effects of Teplizumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• fatigue,
• muscle pain,
• joint pain,
• nausea,
• headache, and
• abnormal blood results (increased liver enzymes, decrease in white blood cells)

Rare side effects of Teplizumab 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 and pediatric dosage

Injectable solution

• 2 mg/2 mL (1 mg/mL) single-dose vial

Type 1 Diabetes Mellitus

Adult and pediatric dosage

• Administer by IV infusion over 30 min every day for 14 consecutive days

Dosage regimen

• Day 1: 65 mcg/m2
• Day 2: 125 mcg/m2
• Day 3: 250 mcg/m2
• Day 4: 500 mcg/m2
• Days 5-14: 1,030 mcg/m2

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.

• Teplizumab has severe interactions with no other drugs.
• Teplizumab has serious interactions with at least 70 other drugs.
• Teplizumab has moderate interactions with the following drugs:
  • efgartigimod alfa
  • isavuconazonium sulfate
• Teplizumab 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 Teplizumab?”

Long-Term Effects

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

Cautions

• Bacterial and viral infections (eg, gastroenteritis, cellulitis, pneumonia, abscess, sepsis) reported; not recommended with active, serious infection or chronic infection other than localized skin infections; monitor for signs and symptoms during and after treatment; if serious infection develops, treat appropriately and discontinue the drug
• Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting, and bronchospasm reported; if severe hypersensitivity reactions occur, discontinue use and treat promptly
• Cytokine release syndrome (CRS)
  • CRS observed in clinical trials during treatment through 28 days after the last dose
  • CRS manifestations included fever, nausea, fatigue, headache, myalgia, arthralgia, increased ALT/AST, and increased total bilirubin
  • These manifestations typically occurred during the first 5 days of treatment
  • To mitigate CRS
  • Premedicate with antipyretics, antihistamines, and/or antiemetics before treatment
  • Monitor liver enzymes during treatment
  • Discontinue treatment in patients who develop elevated ALT or AST is more than 5x ULN or bilirubin is more than 3x ULN
  • Treat symptoms of CRS with antipyretics, antihistamines and/or antiemetics
  • If severe CRS develops, consider temporarily pausing dosing for 1-2 days (and administering the remaining doses to complete the full 14-day course on consecutive days) or discontinuing treatment
• Lymphopenia
• Lymphopenia commonly occurs during treatment
• In most patients who experienced lymphopenia, lymphocyte levels began to recover after day 5 of treatment and returned to pretreatment values within 2 weeks after completion and without dose interruption
• Monitor WBC counts during the treatment period
• Discontinue if prolonged severe lymphopenia (less than 500 cells/mcL lasting for more than 1 week) develops
• Drug interaction overview
  • Vaccinations
  • Administer all age-appropriate vaccinations prior to starting teplizumab
  • Live-attenuated vaccines: Not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment
  • Inactivated or mRNA vaccines: Not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment
  • The safety of immunization with live-attenuated vaccines in treated patients has not been studied
  • Additionally, teplizumab may interfere with the immune response to vaccination and decrease vaccine efficacy

Pregnancy and Lactation

• Available case reports from clinical trials are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Although there are no data on teplizumab, monoclonal antibodies can be actively transported across the placenta, and teplizumab may cause immunosuppression in the utero-exposed infant
• Minimize fetal exposure by avoiding use during pregnancy and at least 30 days (6 half-lives) before a planned pregnancy
• Report pregnancies to Provention Bio, Inc.’s Adverse Event reporting line at 1-844-778-2246
• Clinical considerations
  • Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester
  • Because teplizumab may interfere with the immune response to infections, consider risks and benefits before administering live vaccines to infants exposed to in utero
  • Data are insufficient regarding infant serum levels of teplizumab at birth and the duration of persistence in infant serum after birth to identify a specific time frame to delay live virus immunizations in infants exposed in utero
• Lactation
  • No data are available regarding the presence of teplizumab in either human or animal milk, its effects on breastfed children, or on milk production
  • Endogenous maternal IgG and monoclonal antibodies are transferred into human milk
  • A lactating woman may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after administration to minimize drug exposure to a breastfed child