What this guide covers, and what it leaves alone
Pregnancy, contraception and breastfeeding are the parts of a GLP-1 label that people read most carefully and that the internet paraphrases most loosely. This guide does neither. It reports what the FDA-approved Wegovy® prescribing information says about pregnancy, stopping before a planned pregnancy, fertility and lactation, and what the Zepbound® label says about oral contraceptives, in the labels’ own terms. It does not give advice about conception, contraception or feeding an infant; those are decisions for your provider and, where relevant, your obstetric or pediatric clinician.
This is general information and not medical advice. The labels describe Wegovy® and Zepbound®, the FDA-approved products. Personalized Compounded semaglutide and tirzepatide, which Bodi Envi’s programs may include, are not FDA-approved, were not studied and are not equivalent to the approved products. If you are pregnant, planning a pregnancy or breastfeeding, tell your licensed provider before anything else.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
What the label says about pregnancy
The Wegovy® label’s pregnancy section opens with a pregnancy exposure registry: the manufacturer monitors pregnancy outcomes in women exposed to the medication, and encourages patients and providers to enrol. That is a statement in itself about how much is known.
The risk summary follows. The label says that, based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy, and that available pharmacovigilance data and clinical trial data in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. It states that weight loss offers no benefit to a pregnant patient and may cause fetal harm, that when a pregnancy is recognized the patient should be advised of the risk to a fetus, and that the medication should be discontinued in pregnant patients who are using it for weight reduction.
The animal data the label describes are specific. In pregnant rats given semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at clinically relevant exposures. In rabbits and cynomolgus monkeys, early pregnancy losses and structural abnormalities were observed. The label notes that these effects coincided with pharmacological effects on maternal weight and food intake.
The Zepbound® label’s pregnancy section says the same things in nearly the same words: weight loss offers no benefit to a pregnant patient and may cause fetal harm, discontinue when a pregnancy is recognized, available human data are insufficient, and animal studies showed fetal growth reductions and abnormalities at clinically relevant exposures. It too has a pregnancy exposure registry. Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
Stopping before a planned pregnancy
The Wegovy® label’s section on females and males of reproductive potential contains one instruction, and it is the one most worth knowing in advance: because of the potential for fetal harm, discontinue the medication in patients at least two months before they plan to become pregnant, to account for the long half-life of semaglutide.
The reason is in the label’s pharmacokinetics. Semaglutide has a half-life of approximately one week, and the label states that it will be present in the circulation for about five to seven weeks after the last dose. Two months is the label’s margin for the medication to clear before conception. Because this instruction is about timing, it is one to raise with a provider before a pregnancy is planned rather than after, and it applies to the branded product; a provider applies the same pharmacology to a compounded prescription.
The Zepbound® label gives tirzepatide a shorter half-life, approximately five days, and its reproductive potential section addresses contraception rather than a stopping interval; the pregnancy section’s instruction to discontinue when a pregnancy is recognized stands.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
What the label says about fertility
People searching this topic often want to know whether the medication affects the ability to conceive. The Wegovy® label reports an animal study and nothing in humans. In a combined fertility and embryofetal development study in rats, no effects were observed on male fertility. In females, an increase in estrous cycle length was observed at all dose levels, together with a small reduction in the number of corpora lutea at clinically relevant exposures, and the label describes these effects as likely an adaptive response secondary to the pharmacological effect of semaglutide.
That is the whole of what the label says. It reports no human fertility data, and this guide has no peer reviewed trial to cite on the question, so it makes no claim about semaglutide and human fertility in either direction. Anyone who has read that these medications improve or impair fertility has read something the label does not say.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
What the Zepbound® label says about oral contraceptives
The Zepbound® label carries an instruction that the Wegovy® label does not. In its drug interaction and reproductive potential sections it states that tirzepatide delays gastric emptying, that the delay is largest after the first dose and diminishes over time, and that use of the medication may reduce the efficacy of oral hormonal contraceptives as a result. It advises patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception, for four weeks after starting the medication and for four weeks after each dose escalation, and notes that hormonal contraceptives not administered orally should not be affected.
The Wegovy® label’s oral medications section says that semaglutide delays gastric emptying and may affect the absorption of oral medications, that in clinical pharmacology trials with the 1 mg injection it did not affect the absorption of orally administered medications, and that the effects of oral medications should be monitored; it gives no specific instruction about oral contraceptives. A provider reads both labels; a patient on either molecule who uses an oral contraceptive should raise it.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
What the labels say about breastfeeding
For the Wegovy® injection, the label states that there are no data on the presence of subcutaneously administered semaglutide in human milk, its effects on the breastfed infant, or its effects on milk production. For the Wegovy® tablet, the label advises that breastfeeding is not recommended during treatment, because an absorption enhancer in the tablet formulation is present in human milk and its effects on an infant are unknown.
The Zepbound® label reports a single-dose clinical lactation study in which the concentration of tirzepatide in breast milk was undetectable or low compared with the maternal dose, states that there are no data on effects on the breastfed infant or on milk production, and says the benefits of breastfeeding should be considered along with the mother’s need for the medication and any potential adverse effects.
Neither label makes the decision for anyone. That is a conversation for a provider and, where relevant, the child’s clinician.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
What this means when you talk to a provider
The label’s instructions turn into a short list of things to tell a provider before or during treatment. That you are pregnant, since the label says to discontinue. That you are planning a pregnancy, and when, since the label’s two month interval only works if it is planned for. That you use an oral contraceptive, since the Zepbound® label gives a specific instruction and the Wegovy® label asks for monitoring of oral medications. That you are breastfeeding or intend to. And that any of this changes during treatment, because the assessment describes a moment and pregnancy plans do not stay still.
Bodi Envi’s assessment asks about pregnancy and plans for it because a licensed provider cannot decide safely without knowing. Through Bodi Envi, clinical services for applicable programs are provided by Wasef Health, PC, and a licensed provider determines whether treatment is appropriate for each individual patient and can be reached through the patient portal when circumstances change. Bodi Envi is a telehealth platform and not a medical practice, pharmacy or medication manufacturer. Personalized Compounded semaglutide and tirzepatide are not FDA-approved and are not equivalent to the approved products; the labels cited describe the branded products. This is general information and not medical advice, and your provider is the person to ask.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.