Safety Information

Our Commitment to Safety

At Fifty 410, patient safety is our highest priority. We implement multiple safeguards to ensure you receive safe, effective care:

• Licensed Healthcare Providers: All prescriptions are written by licensed providers who review your complete medical history
• FDA-Registered 503A & 503B Pharmacies: Our compounding partners operate under FDA oversight with Current Good Manufacturing Practices (cGMP)
• LegitScript Certified: Our telehealth platform meets rigorous standards for healthcare legitimacy and compliance
• HIPAA Compliance: Your health information is protected with industry-standard encryption and privacy protocols
• Ongoing Monitoring: Regular check-ins and dose adjustments based on your response and tolerance

Who Should NOT Use GLP-1 Medications

GLP-1 medications are contraindicated (should not be used) in the following populations:

Absolute Contraindications

• Personal or family history of medullary thyroid carcinoma (MTC)
  GLP-1 receptor agonists caused thyroid C-cell tumors in rodent studies
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  Increased risk of MTC in this genetic condition
• Known hypersensitivity to semaglutide, tirzepatide, or any excipients
  Serious hypersensitivity reactions including anaphylaxis have been reported

Relative Contraindications (Use with Caution)

• History of pancreatitis
  Acute pancreatitis has been reported; discontinue if suspected
• Diabetic retinopathy
  Rapid improvement in glucose control may temporarily worsen diabetic retinopathy
• Severe gastrointestinal disease
  Including gastroparesis and inflammatory bowel disease
• Pregnancy or breastfeeding
  Discontinue at least 2 months before planned pregnancy (semaglutide) due to long half-life

Source: FDA Prescribing Information; American Association of Clinical Endocrinology (AACE) Guidelines 2023

Side Effects Profile

The following are common side effects associated with GLP-1 medications. Individual experiences may vary.

Most Common Side Effects

• Nausea - Most common, especially during dose titration
• Diarrhea - Usually temporary
• Vomiting - Typically improves over time
• Constipation - Can be managed with fiber and hydration
• Abdominal Pain - Usually mild
• Headache - Generally temporary
• Fatigue - Often improves as body adjusts
• Dyspepsia - Indigestion or heartburn
• Injection Site Reactions - Mild redness or itching at injection site

Important Notes on Side Effects

• Gastrointestinal side effects typically decrease over time as your body adjusts to the medication. Most patients report significant improvement by weeks 4-8.
• Gradual dose titration minimizes side effects. Starting at a low dose and slowly increasing allows your body to adapt.
• Most patients tolerate the medication well. Side effects are usually manageable and improve with continued use.

Serious Adverse Events

While uncommon, the following serious adverse events have been reported with GLP-1 medications:

Pancreatitis

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists.

• Incidence is rare but requires awareness
• Symptoms: Severe, persistent abdominal pain (may radiate to back), with or without vomiting
• Action: Discontinue promptly if pancreatitis is suspected; do not restart if confirmed

Gallbladder Disease

Cholelithiasis (gallstones) and cholecystitis have been reported in patients on GLP-1 medications.

• Rapid weight loss is a known risk factor for gallstone formation
• Symptoms: Upper right abdominal pain, especially after eating fatty foods

Acute Kidney Injury

Acute kidney injury has been reported, usually associated with dehydration from gastrointestinal adverse reactions.

• Monitor renal function in patients with renal impairment
• Ensure adequate hydration, especially when initiating therapy
• Use caution with concomitant medications that affect renal function

Hypoglycemia

When used with insulin or insulin secretagogues (sulfonylureas), the risk of hypoglycemia is increased.

• Without diabetes: Hypoglycemia is uncommon when GLP-1s are used alone
• With diabetes medications: Dose reduction of insulin or sulfonylureas may be needed

Suicidal Behavior and Ideation

Reports of suicidal behavior and ideation have been reported in patients taking GLP-1 receptor agonists. The FDA is actively monitoring this safety signal.^[13]

• Monitor for new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior
• Contact your healthcare provider immediately if you experience thoughts of self-harm or suicide
• Patients with a history of mental health conditions should discuss risks with their provider
• National Suicide Prevention Lifeline: 988 (call or text)

Diabetic Retinopathy Complications

Rapid improvement in glucose control has been associated with temporary worsening of diabetic retinopathy in patients with type 2 diabetes.

• Patients with a history of diabetic retinopathy should be monitored closely
• Report any vision changes to your healthcare provider immediately

Source: FDA Adverse Event Reporting System (FAERS); Wegovy® and Zepbound® Prescribing Information

Drug Interactions

GLP-1 medications slow gastric emptying, which may affect the absorption of concomitantly administered oral medications.

Medications Requiring Monitoring

Source: Drug interaction studies; FDA Prescribing Information

Special Populations

Pregnancy and Lactation

• Pregnancy Category: Not recommended. Discontinue GLP-1 medications at least 2 months before a planned pregnancy (semaglutide) or 1 month (tirzepatide) due to the long half-life.
• Animal Data: Embryo-fetal toxicity observed in animal reproduction studies at clinically relevant exposures.
• Lactation: Unknown if excreted in human milk; weigh benefits vs. risks.
• Pregnancy Registry: If you become pregnant while taking a GLP-1 medication, pregnancy registries are available through the manufacturers to monitor outcomes. Contact your healthcare provider for enrollment information.
• Birth Control: GLP-1 medications may reduce the effectiveness of oral contraceptives. Consider using a non-oral backup method of contraception or switch to a non-oral contraceptive during treatment.

Pediatric Use

• Semaglutide (Wegovy®): Approved for chronic weight management in patients aged 12+ with initial BMI at or above the 95th percentile (FDA approval December 2022)
• Tirzepatide: Not approved for pediatric use as of current date

Geriatric Use

• No dose adjustment required based on age alone
• Clinical trials included patients up to 75+ years with similar efficacy and safety profiles
• Consider greater sensitivity in some elderly individuals

Renal Impairment

• Mild to moderate: No dose adjustment required
• Severe (eGFR <30): Limited data; use with caution and monitor for GI adverse reactions that could worsen renal function
• End-stage renal disease: Not recommended due to limited experience

Hepatic Impairment

• Mild to moderate: No dose adjustment required
• Severe: Limited data; use with caution

Source: FDA Prescribing Information; Clinical pharmacology studies

Medication Storage and Handling

Before First Use

• Store in refrigerator at 36°F to 46°F (2°C to 8°C)
• Do not freeze; discard if frozen
• Protect from light; keep in original carton

After First Use (In-Use)

• Do not use if solution is cloudy, discolored, or contains particles
• Discard medication that has been frozen or exposed to temperatures above 86°F (30°C)

Shipping Considerations

Fifty 410 ships all medications overnight or 2-day with cold chain packaging to maintain temperature integrity. All orders include insulated containers with gel ice packs.

Source: FDA Prescribing Information for Wegovy®^[1], Zepbound®^[2], Ozempic®^[3], and Mounjaro®^[4]

Hair Loss Treatment Ingredients

Our hair loss treatments contain FDA-approved active ingredients compounded for optimal results. Understanding each component helps you make informed decisions about your treatment.

Finasteride Safety Information

Finasteride is a 5-alpha reductase inhibitor that blocks the conversion of testosterone to dihydrotestosterone (DHT), which is responsible for hair follicle miniaturization in androgenetic alopecia.^[8]

Important Warnings

Common Side Effects

• Decreased libido - Reported in 1.8% of patients in clinical trials
• Erectile dysfunction - Reported in 1.3% of patients
• Ejaculation disorder - Reported in 1.2% of patients
• Breast tenderness or enlargement - Uncommon

Post-Finasteride Syndrome

Some patients have reported persistent sexual, neurological, and physical symptoms after discontinuing finasteride. While this condition is not fully understood, patients should discuss any concerns with their provider.^[9]

Prostate Cancer Screening

Finasteride may decrease serum PSA levels by approximately 50%. Men taking finasteride should inform their healthcare provider before PSA testing. PSA values should be doubled for comparison with normal ranges in untreated men.^[8]

Source: FDA Prescribing Information for Propecia® (finasteride)^[8]

Oral Minoxidil Safety Information

Minoxidil is a vasodilator that promotes hair growth by improving blood flow to hair follicles and extending the anagen (growth) phase of the hair cycle. While topical minoxidil is available over-the-counter, oral minoxidil requires provider supervision.^[10]

Important Warnings

Common Side Effects

• Hypertrichosis - Increased hair growth on face/body (most common, ~20%)
• Fluid retention - Mild peripheral edema
• Lightheadedness - Due to vasodilation
• Increased heart rate - Mild tachycardia in some patients
• Headache - Usually temporary

Contraindications

• Pheochromocytoma
• Pregnancy and breastfeeding
• History of heart failure or significant cardiac disease
• Concurrent use with other vasodilators (without provider guidance)

Monitoring Recommendations

• Baseline blood pressure and heart rate before starting treatment
• ECG recommended for patients with cardiac history
• Monitor for signs of fluid retention

Source: Oral Minoxidil for Hair Loss: Clinical Review^[10]; Gupta AK, et al. J Am Acad Dermatol 2022^[11]

Vitamins in Hair Loss Formulas

Our hair loss formulations include supportive vitamins that play important roles in hair health and follicle function.

Biotin (Vitamin B7)

• Essential cofactor for keratin synthesis
• Generally well-tolerated with minimal side effects
• Lab Interference Warning: Biotin can interfere with certain laboratory tests, including thyroid function tests, troponin, and hormone levels. Inform your healthcare provider and laboratory that you are taking biotin before any blood tests.^[12]

Vitamin D3

• Supports hair follicle cycling and growth
• Deficiency linked to alopecia areata and telogen effluvium
• Excessive doses may cause hypercalcemia (nausea, constipation, weakness)
• Safe at recommended supplementation levels

Vitamin K2

• Works synergistically with Vitamin D3
• Helps direct calcium to appropriate tissues
• Drug Interaction: May reduce the effectiveness of warfarin and other vitamin K antagonists. Patients on anticoagulants should consult their provider.^[13]

NAD+ (Nicotinamide Adenine Dinucleotide) Safety

NAD+ is a coenzyme found in all living cells that plays a critical role in cellular energy production, DNA repair, and metabolic regulation. NAD+ levels naturally decline with age.^[14]

How NAD+ Works

• Essential cofactor for sirtuins (proteins involved in aging and longevity)
• Required for mitochondrial function and ATP production
• Involved in over 500 enzymatic reactions

Common Side Effects

• Flushing - Temporary warmth and redness (most common)
• Nausea - Usually mild and temporary
• Headache - May occur with initial doses
• Fatigue - Paradoxically, some experience initial tiredness
• Digestive discomfort - Mild cramping possible

Precautions

• Limited long-term safety data in humans
• May interact with chemotherapy drugs (discuss with oncologist)
• Not recommended during pregnancy or breastfeeding
• Use caution with diabetes medications (may affect blood sugar)

Source: Rajman L, et al. Cell Metab. 2018^[14]; Yoshino J, et al. Science. 2011^[15]

Sermorelin Safety Information

Sermorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) that stimulates the pituitary gland to produce and release natural growth hormone. Unlike direct growth hormone administration, sermorelin works through the body's natural regulatory pathways.^[16]

Common Side Effects

• Injection site reactions - Redness, swelling, or pain at injection site
• Flushing - Facial flushing, warmth
• Headache - Usually mild
• Dizziness - Temporary lightheadedness
• Hyperactivity - Some patients report increased energy
• Nausea - Usually transient

Contraindications

• Active malignancy - Growth hormone may promote tumor growth
• Diabetic retinopathy - May worsen condition
• Pregnancy and breastfeeding - Not recommended
• Children with closed epiphyses - Not indicated
• Hypersensitivity - To sermorelin or any component

Important Considerations

• Growth hormone affects glucose metabolism; monitor blood sugar if diabetic
• May cause fluid retention and joint pain at higher doses
• Should be administered before bedtime to mimic natural GH release patterns
• Periodic monitoring of IGF-1 levels recommended

Source: FDA Prescribing Information for Geref® (sermorelin)^[16]; Walker RF. Clin Interv Aging. 2006^[17]

Glutathione Safety Information

Glutathione is the body's most abundant antioxidant, consisting of three amino acids: cysteine, glycine, and glutamic acid. It plays a crucial role in detoxification, immune function, and cellular protection against oxidative stress.^[18]

Administration Routes

• Subcutaneous injection - Higher bioavailability than oral forms
• Oral supplements - Variable absorption
• IV infusion - Direct delivery (clinic-based)

Common Side Effects

• Injection site reactions - Minor redness or discomfort
• Bloating or cramping - With oral forms
• Allergic reactions - Rare but possible
• Skin lightening - At high doses over prolonged periods

Precautions

• May interact with chemotherapy medications (consult oncologist)
• Use caution with asthma (inhaled form may trigger bronchospasm)
• Limited data on long-term supplementation safety
• Not recommended during pregnancy without provider guidance

Drug Interactions

• May enhance or reduce the effects of certain chemotherapy drugs
• May affect nitroglycerin effectiveness

Source: Richie JP Jr, et al. Eur J Nutr. 2015^[18]; Pizzorno J. Integr Med. 2014^[19]

Methylene Blue Safety Information

Methylene blue is a synthetic dye with a long history in medicine, originally used to treat malaria and methemoglobinemia. Recent research suggests potential benefits for mitochondrial function and neuroprotection at low doses.^[20]

Common Side Effects

• Blue-green discoloration of urine - Expected and harmless
• Blue staining of skin and mucous membranes - Temporary
• Nausea and vomiting - Usually dose-related
• Dizziness - Especially at higher doses
• Headache - Usually mild
• Abdominal pain - Occasional

Absolute Contraindications

• G6PD deficiency - Can cause severe hemolysis (red blood cell destruction)
• Concurrent use with serotonergic medications - Risk of serotonin syndrome
• Severe renal impairment - Reduced clearance
• Pregnancy and breastfeeding - Not recommended

Required Screening

G6PD testing is required before starting methylene blue therapy. G6PD deficiency affects approximately 400 million people worldwide and is more common in those of African, Mediterranean, Middle Eastern, and Southeast Asian descent.^[21]

Drug Interactions

Source: FDA Drug Safety Communication^[20]; Clifton J, Leikin JB. Am J Ther. 2003^[21]; Rojas JC, et al. CNS Neurol Disord Drug Targets. 2012^[22]

Report Adverse Events to the FDA

If you experience a serious side effect or adverse event while taking GLP-1 medication, you are encouraged to report it to the FDA. Your report can help the FDA identify potential safety issues.

• Phone: 1-800-FDA-1088 (1-800-332-1088)
• Online: www.fda.gov/medwatch
• Mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

You can also report adverse events directly to Fifty 410 at [email protected], and we will assist with proper documentation and reporting.

Medication Administration

GLP-1 medications are administered as subcutaneous (under the skin) injections once weekly.

Injection Sites

• Abdomen: At least 2 inches from the navel
• Thigh: Front of the thigh
• Upper arm: Back of the upper arm (may need assistance)

Best Practices

• Inject on the same day each week (e.g., every Sunday)
• Rotate injection sites to prevent skin reactions
• Clean the injection site with an alcohol swab before injecting
• Allow medication to reach room temperature before injection for comfort
• Do not inject into areas that are tender, bruised, red, or hard

Supplies Included

All Fifty 410 orders include:

• Your prescribed medication
• Injection needles/syringes
• Alcohol prep pads
• Sharps container for safe disposal
• Injection instructions

References

This safety information is compiled from FDA-approved prescribing information, peer-reviewed medical literature, and clinical guidelines. Numbers in brackets [X] throughout this page correspond to the references below.

GLP-1 Medications

1. FDA. Wegovy® (semaglutide) injection, for subcutaneous use. Prescribing Information. Novo Nordisk. Revised 2024. FDA Label
2. FDA. Zepbound® (tirzepatide) injection, for subcutaneous use. Prescribing Information. Eli Lilly. Revised 2024. FDA Label
3. FDA. Ozempic® (semaglutide) injection, for subcutaneous use. Prescribing Information. Novo Nordisk. Revised 2024. FDA Label
4. FDA. Mounjaro® (tirzepatide) injection, for subcutaneous use. Prescribing Information. Eli Lilly. Revised 2024. FDA Label
5. FDA Drug Safety Communication. FDA investigating reports of suicidal thoughts or actions in patients taking GLP-1 receptor agonist medications. January 2024. FDA Safety Communication
6. FDA. Compounding and the FDA: Questions and Answers. FDA.gov
7. FDA. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. FDA.gov/MedWatch

Hair Loss Treatments

8. FDA. Propecia® (finasteride) tablets, for oral use. Prescribing Information. Merck & Co. Revised 2023. FDA Label
9. Traish AM. Post-finasteride syndrome: a surmountable challenge for clinicians. Fertil Steril. 2020;113(1):21-50. PubMed
10. Randolph M, Tosti A. Oral minoxidil treatment for hair loss: A review of efficacy and safety. J Am Acad Dermatol. 2021;84(3):737-746. PubMed
11. Gupta AK, et al. Efficacy of low-dose oral minoxidil in androgenetic alopecia. J Am Acad Dermatol. 2022;87(2):388-392. PubMed
12. FDA Safety Communication. The FDA Warns that Biotin May Interfere with Lab Tests. November 2017. FDA Safety Communication
13. Booth SL. Vitamin K: food composition and dietary intakes. Food Nutr Res. 2012;56:5505. PubMed

Longevity Treatments

14. Rajman L, Chwalek K, Sinclair DA. Therapeutic Potential of NAD-Boosting Molecules: The In Vivo Evidence. Cell Metab. 2018;27(3):529-547. PubMed
15. Yoshino J, Mills KF, Yoon MJ, Imai S. Nicotinamide mononucleotide, a key NAD+ intermediate, treats the pathophysiology of diet- and age-induced diabetes in mice. Cell Metab. 2011;14(4):528-536. PubMed
16. FDA. Geref® (sermorelin acetate) for injection. Prescribing Information. Serono Laboratories. FDA Label
17. Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging. 2006;1(4):307-308. PMC
18. Richie JP Jr, et al. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. Eur J Nutr. 2015;54(2):251-263. PubMed
19. Pizzorno J. Glutathione! Integr Med (Encinitas). 2014;13(1):8-12. PMC
20. FDA Drug Safety Communication. FDA warns of risk of serious CNS reactions when methylene blue is given with serotonergic psychiatric medications. 2011. FDA Safety Communication
21. Clifton J 2nd, Leikin JB. Methylene blue. Am J Ther. 2003;10(4):289-291. PubMed
22. Rojas JC, Bruchey AK, Gonzalez-Lima F. Neurometabolic mechanisms for memory enhancement and neuroprotection of methylene blue. Prog Neurobiol. 2012;96(1):32-45. PubMed

Questions About Safety?

Our medical team is available to answer questions about medication safety for all of our treatments. For non-emergency questions:

• Email: [email protected]
• Patient Portal: Message your care team directly

For medical emergencies, call 911 or go to your nearest emergency room.