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Drug Interactions between lonapegsomatropin and Nuvelle TS Phase I

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

estradiol lonapegsomatropin

Applies to: Nuvelle TS Phase I (estradiol) and lonapegsomatropin

MONITOR: Coadministration of oral estrogen replacement therapy may diminish the therapeutic effects of human growth hormone. Some of the pharmacodynamic effects of human growth hormone are primarily mediated by insulin-like growth factor 1 (IGF-1), and orally administered estrogen can suppress growth hormone (GH)-dependent IGF-1 production in the liver. Gender differences have been shown in responsiveness to GH, with women requiring higher doses than men to achieve a similar response. The results of one study demonstrated that women taking oral estrogen required higher doses of GH to achieve an adequate response compared with men or women using transdermal estrogen. In addition, the study showed that GH requirements were also higher for GH-deficient women receiving primarily oral estrogen replacement therapy than for eugonadal GH-deficient women. This interaction does not appear to apply to non-orally administered estrogens.

MANAGEMENT: Patients receiving human growth hormone with oral estrogen replacement therapy should be monitored for potentially diminished GH efficacy. A higher dosage of growth hormone may be required to maintain serum IGF-1 levels within the normal age-appropriate range in order to achieve the defined treatment goal. Please consult individual product labeling for the appropriate initial dosage of growth hormone recommended. Dosage adjustments as well as clinical and laboratory monitoring should be considered following the addition or discontinuation of oral estrogen replacement therapy during use of growth hormone.

References

  1. (2003) "Product Information. Humatrope (somatropin)." Lilly, Eli and Company
  2. (2004) "Product Information. Zorbtive (somatropin)." Serono Laboratories Inc
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."
  5. Cook DM, Ludlam WH, Cook MB (1999) "Route of estrogen administration helps to determine growth hormone (GH) replacement dose in GH-deficient adults." J Clin Endocrinol Metab, 84, p. 3956-60
View all 5 references

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Drug and food interactions

Minor

estradiol food

Applies to: Nuvelle TS Phase I (estradiol)

Coadministration with grapefruit juice may increase the bioavailability of oral estrogens. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall induced by certain compounds present in grapefruits. In a small, randomized, crossover study, the administration of ethinyl estradiol with grapefruit juice (compared to herbal tea) increased peak plasma drug concentration (Cmax) by 37% and area under the concentration-time curve (AUC) by 28%. Based on these findings, grapefruit juice is unlikely to affect the overall safety profile of ethinyl estradiol. However, as with other drug interactions involving grapefruit juice, the pharmacokinetic alterations are subject to a high degree of interpatient variability. Also, the effect on other estrogens has not been studied.

References

  1. Weber A, Jager R, Borner A, et al. (1996) "Can grapefruit juice influence ethinyl estradiol bioavailability?" Contraception, 53, p. 41-7
  2. Schubert W, Eriksson U, Edgar B, Cullberg G, Hedner T (1995) "Flavonoids in grapefruit juice inhibit the in vitro hepatic metabolism of 17B-estradiol." Eur J Drug Metab Pharmacokinet, 20, p. 219-24

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.