Skytrofa 7.6mg Inj Cartridge
It is used to help with growth and to treat growth hormone deficiency.
Drug Class
Growth Hormone Receptor Agonist
Pharmacologic Class
Recombinant Human Growth Hormone (rhGH) analog, PEGylated
Pregnancy Category
Not available
FDA Approved
Aug 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Skytrofa is a medicine given as a once-weekly injection to children aged 1 year and older who have growth hormone deficiency. It works by providing a long-acting form of the natural growth hormone that their body needs to grow taller and develop properly.
How to Use This Medicine
Administering This Medication
To ensure your child receives this medication correctly, follow the instructions provided by their doctor. Carefully read all accompanying information and follow the instructions precisely. This medication is administered via injection into the fatty tissue on the right or left side of the stomach, thigh, or buttocks.
If you will be giving your child the injection, their doctor or nurse will provide guidance on the proper technique. Make sure you understand how to use this medication before proceeding. Refer to the instructions for use that come with the medication, and if you have any questions or concerns, consult with the doctor or pharmacist.
Before use, if the medication has been stored in the refrigerator, allow it to reach room temperature for 15 minutes. Do not heat the medication. This medication requires mixing before use; follow the instructions provided by the doctor to ensure proper preparation.
Important Administration Guidelines
Rotate the injection site with each dose to minimize the risk of tissue damage.
Avoid injecting through clothing.
Do not administer the medication into skin that is irritated, bruised, red, infected, hard, or scarred.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
After mixing, do not refrigerate the medication.
Use the medication within 4 hours of preparation.
Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with a doctor or pharmacist.
Storage and Disposal
Store the medication in the refrigerator to maintain its potency. Do not freeze the medication. Keep it in the original outer carton to protect it from light. If necessary, you can store the medication at room temperature for up to 6 months. Record the date you remove the medication from the refrigerator. You can return the medication to the refrigerator within the 6-month period. Discard the medication if it is not used within 6 months of being removed from the refrigerator.
Missed Dose
If you miss a dose, administer it as soon as you remember. However, if your child misses a dose by more than 2 days, skip the missed dose and resume the normal schedule. Do not give two doses within 5 days of each other.
To ensure your child receives this medication correctly, follow the instructions provided by their doctor. Carefully read all accompanying information and follow the instructions precisely. This medication is administered via injection into the fatty tissue on the right or left side of the stomach, thigh, or buttocks.
If you will be giving your child the injection, their doctor or nurse will provide guidance on the proper technique. Make sure you understand how to use this medication before proceeding. Refer to the instructions for use that come with the medication, and if you have any questions or concerns, consult with the doctor or pharmacist.
Before use, if the medication has been stored in the refrigerator, allow it to reach room temperature for 15 minutes. Do not heat the medication. This medication requires mixing before use; follow the instructions provided by the doctor to ensure proper preparation.
Important Administration Guidelines
Rotate the injection site with each dose to minimize the risk of tissue damage.
Avoid injecting through clothing.
Do not administer the medication into skin that is irritated, bruised, red, infected, hard, or scarred.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
After mixing, do not refrigerate the medication.
Use the medication within 4 hours of preparation.
Dispose of needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions, consult with a doctor or pharmacist.
Storage and Disposal
Store the medication in the refrigerator to maintain its potency. Do not freeze the medication. Keep it in the original outer carton to protect it from light. If necessary, you can store the medication at room temperature for up to 6 months. Record the date you remove the medication from the refrigerator. You can return the medication to the refrigerator within the 6-month period. Discard the medication if it is not used within 6 months of being removed from the refrigerator.
Missed Dose
If you miss a dose, administer it as soon as you remember. However, if your child misses a dose by more than 2 days, skip the missed dose and resume the normal schedule. Do not give two doses within 5 days of each other.
Lifestyle & Tips
- Administer the injection exactly as prescribed by your doctor, usually once a week on the same day.
- Learn proper injection technique from a healthcare professional, including site rotation to prevent skin problems.
- Store the medicine in the refrigerator as directed. Do not freeze.
- Keep all scheduled appointments for blood tests and doctor visits to monitor treatment effectiveness and safety.
- Maintain a balanced diet and regular physical activity as recommended by your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 1 year of age.
Child:
0.24 mg/kg once weekly via subcutaneous injection. Dose adjusted based on IGF-1 levels and growth response.
Adolescent:
0.24 mg/kg once weekly via subcutaneous injection. Dose adjusted based on IGF-1 levels and growth response. Treatment should be discontinued once epiphyses are closed.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor IGF-1 levels closely.
Moderate:
No specific dose adjustment recommended, but monitor IGF-1 levels closely.
Severe:
Use with caution; monitor IGF-1 levels closely and adjust dose as needed. Limited data available.
Dialysis:
Use with caution; monitor IGF-1 levels closely and adjust dose as needed. Limited data available.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor IGF-1 levels closely.
Moderate:
No specific dose adjustment recommended, but monitor IGF-1 levels closely.
Severe:
Use with caution; monitor IGF-1 levels closely and adjust dose as needed. Limited data available.
Pharmacology
Mechanism of Action
Lonapegsomatropin is a prodrug of somatropin. It is a long-acting C-terminally PEGylated somatropin. After subcutaneous injection, it undergoes slow proteolytic cleavage of the PEG moiety, releasing somatropin. Somatropin binds to growth hormone (GH) receptors on target cells, stimulating linear growth in pediatric patients with GHD. It promotes protein anabolism, lipid mobilization, and carbohydrate metabolism.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for the prodrug, designed for sustained release.
Tmax:
Approximately 84 hours (for somatropin released from lonapegsomatropin)
FoodEffect:
Not applicable (subcutaneous injection)
Distribution:
Vd:
Approximately 0.07 L/kg (for somatropin)
ProteinBinding:
Low
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 25-48 hours (for somatropin released from lonapegsomatropin)
Clearance:
Not precisely quantified for lonapegsomatropin; somatropin clearance is primarily renal.
ExcretionRoute:
Renal (for somatropin)
Unchanged:
Not applicable (prodrug)
Pharmacodynamics
OnsetOfAction:
Biochemical effects (e.g., IGF-1 increase) within days; clinical growth effects are long-term.
PeakEffect:
IGF-1 levels peak around 3-4 days post-dose.
DurationOfAction:
Sustained effect over 7 days, allowing for once-weekly dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If your child exhibits any of the following symptoms, contact their doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of low thyroid levels, such as:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ Burning, numbness, or tingling sensations that are not normal
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
A skin lump or growth
Changes in the color or size of a mole
Skin breakdown at the site of application
Unexplained bruising or bleeding
Muscle or joint pain
Burning, numbness, pain, or tingling in the hands, arms, wrists, legs, or feet
Children using this medication can rarely experience a bone problem in the hip (slipped growth plate); seek medical attention if your child experiences hip or knee pain or a limp
Severe bone problems have occurred with this medication; contact the doctor if your child experiences new or worsening bone pain
Raised pressure in the head has rarely occurred, particularly in patients with Turner syndrome or Prader-Willi syndrome; seek medical attention if your child experiences:
+ Changes in vision
+ Severe headache
+ Upset stomach
+ Vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If your child experiences any of the following side effects or any other symptoms that concern you, contact their doctor or seek medical attention:
Upset stomach or vomiting
* Stomach pain or diarrhea
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your child's doctor. Always contact their doctor for medical advice regarding side effects.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If your child exhibits any of the following symptoms, contact their doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of low thyroid levels, such as:
+ Constipation
+ Sensitivity to cold
+ Memory problems
+ Mood changes
+ Burning, numbness, or tingling sensations that are not normal
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
A skin lump or growth
Changes in the color or size of a mole
Skin breakdown at the site of application
Unexplained bruising or bleeding
Muscle or joint pain
Burning, numbness, pain, or tingling in the hands, arms, wrists, legs, or feet
Children using this medication can rarely experience a bone problem in the hip (slipped growth plate); seek medical attention if your child experiences hip or knee pain or a limp
Severe bone problems have occurred with this medication; contact the doctor if your child experiences new or worsening bone pain
Raised pressure in the head has rarely occurred, particularly in patients with Turner syndrome or Prader-Willi syndrome; seek medical attention if your child experiences:
+ Changes in vision
+ Severe headache
+ Upset stomach
+ Vomiting
Other Possible Side Effects
Most medications can cause side effects, but many people experience none or only mild symptoms. If your child experiences any of the following side effects or any other symptoms that concern you, contact their doctor or seek medical attention:
Upset stomach or vomiting
* Stomach pain or diarrhea
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your child's doctor. Always contact their doctor for medical advice regarding side effects.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache, especially with nausea, vomiting, or vision changes (e.g., blurred vision, double vision) – could indicate increased pressure in the brain.
- New or unusual skin growths, or changes in existing moles – report these to your doctor.
- Limping, or new/worsening hip or knee pain – could indicate a bone problem.
- Signs of a serious allergic reaction, such as rash, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing.
- Increased thirst or urination – could be a sign of high blood sugar.
Before Using This Medicine
Before Your Child Takes This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
If your child is allergic to this medication, any of its components, or any other substances, including foods or drugs. Please describe the allergic reaction and its symptoms.
If your child has any of the following health conditions:
+ Breathing problems, such as sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
If your child has Prader-Willi syndrome and is severely overweight, experiences breathing difficulties, or has sleep apnea
If your child's bones have stopped growing (closed epiphyses)
This list is not exhaustive, and it is crucial to discuss all your child's medications (prescription, over-the-counter, natural products, and vitamins) and health problems with the doctor and pharmacist. To ensure safe treatment, you must verify that it is safe to administer this medication with all your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication your child is taking without consulting the doctor.
It is essential to inform your doctor about the following:
If your child is allergic to this medication, any of its components, or any other substances, including foods or drugs. Please describe the allergic reaction and its symptoms.
If your child has any of the following health conditions:
+ Breathing problems, such as sleep apnea
+ Cancer or other tumors, including brain tumors
+ Diabetic eye disease
+ Recent illness after open heart surgery, stomach surgery, or accidental injury
If your child has Prader-Willi syndrome and is severely overweight, experiences breathing difficulties, or has sleep apnea
If your child's bones have stopped growing (closed epiphyses)
This list is not exhaustive, and it is crucial to discuss all your child's medications (prescription, over-the-counter, natural products, and vitamins) and health problems with the doctor and pharmacist. To ensure safe treatment, you must verify that it is safe to administer this medication with all your child's other medications and health conditions. Never start, stop, or adjust the dosage of any medication your child is taking without consulting the doctor.
Precautions & Cautions
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication.
Your child may be at risk for high blood sugar, including the development of new-onset diabetes or worsening of existing diabetes. Monitor your child's blood sugar levels as directed by their doctor. Regular blood work and eye exams are also crucial, as scheduled by their doctor.
This medication may interfere with certain laboratory tests. Be sure to notify all healthcare providers and laboratory personnel that your child is taking this medication.
If your child experiences any changes in weight, consult with their doctor, as the dosage of this medication may need to be adjusted.
Do not share this medication, needles, or syringes with anyone, even if the needle has been changed, as this can lead to the transmission of infections, including those that may not be immediately apparent.
Be aware that this medication can cause an excess of fluid in the body, which may lead to heart failure in some cases. If your child exhibits symptoms such as shortness of breath, significant weight gain, or swelling in the arms or legs, contact their doctor immediately.
If your child has scoliosis (an abnormal curvature of the spine), consult with their doctor, as this medication may exacerbate the condition in children who are still growing.
If your child has a history of cancer or tumors, or is currently being treated for cancer, discuss the potential risks with their doctor. This medication may increase the risk of cancer or tumor growth, as well as the development of new tumors in some patients.
Children with Prader-Willi syndrome are at a higher risk for severe and potentially life-threatening respiratory problems. This risk may be increased in children who have sleep apnea, respiratory infections, airway obstruction, or are severely overweight. If your child experiences a fever of 100.4°F (38°C) or higher, cough, sore throat, shortness of breath, chest pain or discomfort, new or worsening snoring, or abnormal breathing during sleep, contact their doctor immediately.
If your child is pregnant or breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.
Your child may be at risk for high blood sugar, including the development of new-onset diabetes or worsening of existing diabetes. Monitor your child's blood sugar levels as directed by their doctor. Regular blood work and eye exams are also crucial, as scheduled by their doctor.
This medication may interfere with certain laboratory tests. Be sure to notify all healthcare providers and laboratory personnel that your child is taking this medication.
If your child experiences any changes in weight, consult with their doctor, as the dosage of this medication may need to be adjusted.
Do not share this medication, needles, or syringes with anyone, even if the needle has been changed, as this can lead to the transmission of infections, including those that may not be immediately apparent.
Be aware that this medication can cause an excess of fluid in the body, which may lead to heart failure in some cases. If your child exhibits symptoms such as shortness of breath, significant weight gain, or swelling in the arms or legs, contact their doctor immediately.
If your child has scoliosis (an abnormal curvature of the spine), consult with their doctor, as this medication may exacerbate the condition in children who are still growing.
If your child has a history of cancer or tumors, or is currently being treated for cancer, discuss the potential risks with their doctor. This medication may increase the risk of cancer or tumor growth, as well as the development of new tumors in some patients.
Children with Prader-Willi syndrome are at a higher risk for severe and potentially life-threatening respiratory problems. This risk may be increased in children who have sleep apnea, respiratory infections, airway obstruction, or are severely overweight. If your child experiences a fever of 100.4°F (38°C) or higher, cough, sore throat, shortness of breath, chest pain or discomfort, new or worsening snoring, or abnormal breathing during sleep, contact their doctor immediately.
If your child is pregnant or breastfeeding, consult with their doctor to discuss the potential benefits and risks to both your child and the baby.
Overdose Information
Overdose Symptoms:
- Acute overdose: Initially, low blood sugar (hypoglycemia), followed by high blood sugar (hyperglycemia).
- Chronic overdose: Signs and symptoms of gigantism (in children) or acromegaly (in adults, though not indicated for adults), such as excessive growth, enlarged hands/feet, joint pain, and other metabolic disturbances.
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. For non-emergencies, contact Poison Control at 1-800-222-1222. Management is symptomatic and supportive, focusing on monitoring blood glucose levels and managing any metabolic imbalances.
Drug Interactions
Major Interactions
- Glucocorticoids (may inhibit growth-promoting effects of lonapegsomatropin)
Moderate Interactions
- Thyroid hormones (may require dose adjustment of thyroid hormone)
- Insulin and/or other antidiabetic agents (may require dose adjustment due to potential for insulin resistance)
- CYP450-metabolized drugs (especially CYP3A4 substrates, as GH can induce CYP450 enzymes)
Monitoring
Baseline Monitoring
IGF-1 (Insulin-like Growth Factor-1)
Rationale: To establish baseline levels and guide initial dosing.
Timing: Prior to initiation of therapy
Thyroid Function (TSH, Free T4)
Rationale: To assess for pre-existing thyroid dysfunction, which can affect growth response.
Timing: Prior to initiation of therapy
Glucose (Fasting Glucose or HbA1c)
Rationale: To assess for pre-existing glucose intolerance or diabetes.
Timing: Prior to initiation of therapy
Bone Age
Rationale: To assess skeletal maturity and predict growth potential.
Timing: Prior to initiation of therapy
Height and Weight
Rationale: To establish baseline growth parameters.
Timing: Prior to initiation of therapy
Routine Monitoring
IGF-1
Frequency: Approximately 4 weeks after initiation or dose change, then every 3-6 months or as clinically indicated.
Target: Within age- and sex-appropriate reference range.
Action Threshold: If IGF-1 is consistently above the upper limit of the age- and sex-appropriate reference range, reduce dose. If IGF-1 is consistently below the lower limit and growth response is suboptimal, consider dose increase.
Thyroid Function (TSH, Free T4)
Frequency: Every 6-12 months or as clinically indicated.
Target: Normal range.
Action Threshold: Treat hypothyroidism if detected, as it can impair growth response.
Glucose (Fasting Glucose or HbA1c)
Frequency: Annually or as clinically indicated, especially if risk factors for diabetes are present.
Target: Normal range.
Action Threshold: If hyperglycemia develops, manage appropriately and consider dose adjustment of lonapegsomatropin.
Height and Weight
Frequency: Every 3-6 months.
Target: Consistent growth velocity towards target height.
Action Threshold: Suboptimal growth velocity may indicate need for dose adjustment or investigation of other causes.
Bone Age
Frequency: Annually.
Target: Appropriate for chronological age.
Action Threshold: Accelerated bone age may indicate need for dose adjustment or discontinuation if epiphyses are closing.
Fundoscopic examination (for papilledema)
Frequency: As clinically indicated, especially if symptoms of intracranial hypertension occur.
Target: Normal optic disc.
Action Threshold: If papilledema is present, discontinue therapy and evaluate for benign intracranial hypertension.
Scoliosis screening
Frequency: Regularly during rapid growth periods.
Target: No significant spinal curvature.
Action Threshold: If scoliosis progresses, manage appropriately.
Symptom Monitoring
- Severe or recurrent headache
- Visual changes (e.g., blurred vision, double vision)
- Nausea and/or vomiting (signs of benign intracranial hypertension)
- Limping or hip/knee pain (signs of slipped capital femoral epiphysis or Legg-Calvé-Perthes disease)
- New or worsening skin lesions/moles (potential for malignancy)
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
- Changes in thirst or urination (signs of glucose intolerance)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of lonapegsomatropin in pregnant women. Animal reproduction studies have not shown evidence of harm to the fetus. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Insufficient data to assess risk.
Second Trimester:
Insufficient data to assess risk.
Third Trimester:
Insufficient data to assess risk.
Lactation
It is unknown whether lonapegsomatropin is excreted in human milk. Many drugs are excreted in human milk, and there is a potential for serious adverse reactions in the breastfed infant. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk unknown; caution advised.
Pediatric Use
Skytrofa is indicated for the treatment of pediatric patients 1 year and older with growth hormone deficiency. Safety and effectiveness have not been established in pediatric patients less than 1 year of age.
Geriatric Use
Skytrofa is not indicated for use in geriatric patients. Safety and efficacy have not been established in this population.
Clinical Information
Clinical Pearls
- Skytrofa is the first once-weekly growth hormone treatment approved for pediatric patients with GHD, offering a significant reduction in injection frequency compared to daily somatropin.
- It is a prodrug that slowly releases somatropin, providing sustained therapeutic levels.
- Careful monitoring of IGF-1 levels is crucial for dose titration to ensure efficacy and minimize potential side effects.
- Contraindicated in patients with active malignancy, closed epiphyses, acute critical illness, or active proliferative or severe non-proliferative diabetic retinopathy.
- Patients and caregivers must be thoroughly trained on proper subcutaneous injection technique and site rotation.
- Hypothyroidism can develop or worsen during GH therapy and should be treated to optimize growth response.
Alternative Therapies
- Other daily recombinant human growth hormone (rhGH) products (e.g., Norditropin [somatropin], Genotropin [somatropin], Humatrope [somatropin], Saizen [somatropin], Omnitrope [somatropin], Zomacton [somatropin])
- Other long-acting growth hormone products (e.g., Ngenla [somatrogon])
Cost & Coverage
Average Cost:
High, typically several thousand dollars per cartridge
Insurance Coverage:
Specialty Tier, often requires prior authorization and may have specific criteria for coverage.
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe and effective treatment, never share your child's medication with others, and do not administer someone else's medication to your child. Some medications may include an additional patient information leaflet; if you have any questions or concerns about this medication, consult with your child's doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time it occurred.