Tzield (teplizumab-mzwv)

No dosing information is available for this tab.

Teplizumab-mzwv is available in a single-dose vial as a clear and colorless solution for IV infusion after dilution. Do not use if particulate matter or coloration is seen upon vial inspection.

Do not administer 2 doses of teplizumab-mzwv on the same day. If a planned infusion is missed, resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course.

Store teplizumab-mzwv at 2-8degreesC; do not freeze. Store upright and in original carton to protect from light.

Start the infusion of teplizumab-mzwv within 2 hours of preparation. If not used immediately, store infusion solution at 15-30degreesC and complete infusion within 4 hours of preparation. Discard if not administered within 4 hours of preparation.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Most common adverse reactions (>10%) associated with teplizumab-mzwv use in clinical trials were lymphopenia, rash, leukopenia, and headache.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The safety and effectiveness of teplizumab-mzwv to delay the onset of Stage 3 T1D have been established in pediatric patients 8 years of age and older with Stage 2 T1D. Use of teplizumab-mzwv for this indication is supported by evidence from a study in adults and pediatric patients 8 years of age and older (including 29 pediatric patients). Adverse reactions observed in pediatric patients who received teplizumab-mzwv were consistent with those reported in adult patients.

The safety and effectiveness of teplizumab-mzwv have not been established in pediatric patients younger than 8 years of age.

Available case reports from clinical trials with teplizumab-mzwv 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-mzwv, monoclonal antibodies can be actively transported across the placenta, and teplizumab-mzwv may cause immunosuppression in the utero-exposed infant. To minimize exposure to a fetus, avoid use of teplizumab-mzwv during pregnancy and forat least 30 days (6 half-lives) prior to planned pregnancy. Report pregnancies to Provention Bio, Inc.'s Adverse Event reporting line at 1-844-778-2246.

Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because teplizumab-mzwv may interfere with theimmune response to infections, consider risks and benefits prior to administering live vaccines to infants exposed to teplizumab-mzwv in utero. There are insufficient data regarding infant serum levels of teplizumab-mzwv at birth and the duration of persistence of teplizumab-mzwv in infant serum after birth to identify a specific timeframe to delay live virus immunizations in infants exposed in utero.

In an embryo-fetal developmental toxicity study in pregnant mice, an increase in post-implantation loss occurred in the 20 mg/kg group, in the presence of maternal toxicity.

In a pre- and postnatal development toxicity study in pregnant mice, reductions in T cell populations,increases in B cells, and a reduction in the adaptive immune response to keyhole limpet hemocyanin (KLH) were observed in the offspring on postnatal days 35 and 84 at 20 mg/kg. A trend towards reduction in fertility was observed in the offspring of dams administered the murine surrogate antibody at 20 mg/kg. The human relevance of this finding is unknown.

There are no data on the presence of teplizumab-mzwv in either human or animal milk, the effects on the breastfed child, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk. The effects of local GI exposure and limited systemic exposure in the breastfed infant to teplizumab-mzwv are unknown.

Although the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for teplizumab-mzwv and any potential adverse effects on the breastfed child from teplizumab-mzwv or from the underlying maternal condition, a lactating woman may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after teplizumab-mzwv administration to minimize drug exposure to a breastfed child.

The manufacturer makes no recommendation for dosage adjustment in geriatric patients.

Stage 2 T1D is largely a condition that occurs in pediatric and younger adult patients. Clinical studies of teplizumab-mzwv to delay the onset of Stage 3 T1D did not include patients 65 years of age and older.