Astagraf

Question 1

Is it safe to take ASTAGRAF XL during pregnancy?

Accepted Answer

No, ASTAGRAF XL can cause fetal harm when administered to a pregnant woman. Infants exposed to tacrolimus in utero are at risk of prematurity, birth defects, low birth weight, and fetal distress. Women of reproductive potential should discuss family planning options with their healthcare provider before starting treatment with ASTAGRAF XL. Additionally, there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ASTAGRAF XL during pregnancy. Healthcare providers are encouraged to advise their patients to register by contacting the Transplantation Pregnancy Registry International at 1-877-955-6877 or https://www.transplantpregnancyregistry.org/.

Question 2

What are the risks of taking ASTAGRAF XL during pregnancy?

Accepted Answer

Infants exposed to tacrolimus in utero are at risk of prematurity, birth defects, low birth weight, and fetal distress. The background risk of major birth defects and miscarriage in the indicated population is unknown. Clinical studies of ASTAGRAF XL in pregnant women have not been conducted; safety data is from the Transplantation Pregnancy Registry International (TPRI) and postmarketing surveillance.

Question 3

Can breastfeeding mothers take ASTAGRAF XL?

Accepted Answer

Controlled lactation studies have not been conducted in humans, but tacrolimus has been reported to be present in human milk. The effects of tacrolimus on the breastfed infant or on milk production have not been assessed. Tacrolimus is excreted in rat milk and in peri-/postnatal rat studies, exposure to tacrolimus during the postnatal period was associated with developmental toxicity in the offspring at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ASTAGRAF XL and any potential adverse effects on the breastfed child from ASTAGRAF XL or from the underlying maternal condition.

Question 4

Is there a difference in response to ASTAGRAF XL between elderly and younger patients?

Accepted Answer

Clinical studies of ASTAGRAF XL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Question 5

What should be done for patients with renal or hepatic impairment?

Accepted Answer

The pharmacokinetics of tacrolimus in patients with renal impairment was similar to that in healthy subjects with normal renal function. However, due to its potential for nephrotoxicity, monitoring of renal function in patients with renal impairment is recommended; tacrolimus dosage should be reduced if indicated.

MMF = Mycophenolate mofetil
Recommended ASTAGRAF XL Initial Dosage
Patient Population	Initial Oral Dosage	Whole Blood Trough Concentration Range
ADULT
With basiliximab, MMF and steroids	0.15 to 0.2 mg/kg once daily prior to reperfusion or within 48 hours of completion of transplant	* Month 1: 7‑15 ng/mL * Months 2-6: 5‑15 ng/mL * > 6 Months: 5‑10 ng/mL
With MMF and steroids, without basiliximab induction	* First dose (pre-operative): 0.1 mg/kg, within 12 hours prior to reperfusion * Subsequent doses (post-operative): 0.2 mg/kg once daily at least 4 hours after pre-operative dose and within 12 hours after reperfusion	* Month 1: 10‑15 ng/mL * Months 2-6: 5‑15 ng/mL * > 6 Months: 5‑10 ng/mL
PEDIATRIC
With basiliximab, MMF and steroids	0.3 mg/kg once daily, administered within 24 hours following reperfusion	* Month 1: 10‑20 ng/mL * > Month 1: 5‑15 ng/mL

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