Serostim
Serostim (somatropin) is an injection used to treat people with HIV-related wasting. It's a human growth hormone (hGH) therapy that works by raising lean body mass, promoting weight gain, and improving physical endurance. The medication comes in a vial and needs to be reconstituted (or mixed) with the water provided in the package. The dosage is based on your weight and is given as a shot under the skin once a day at bedtime. Common side effects include joint pain, muscle pain, and swelling in the hands and feet.
What is Serostim (somatropin)?
What is Serostim (somatropin) used for?
How Serostim (somatropin) works
Serostim (somatropin) is a recombinant human growth hormone medication. It acts like our body's natural growth hormone to promote growth and prevent muscle breakdown.
Drug facts
Side effects of Serostim (somatropin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Swelling in the hands and feet (26-45%)
- Joint pain (36-37%)
- Muscle pain (12-30%)
- Pain in the hands and feet (19%)
- Loss of sensation (5-15%)
- Joint wear (8-11%)
- Tingling or numbness (8-11%)
Less Common Side Effects
- Nausea
- Tiredness
- Carpal tunnel
- Enlarged breasts in men
- High blood sugar
- High triglycerides (fat) in the blood
Serostim (somatropin) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Swelling of the pancreas (pancreatitis): nausea, vomiting, severe abdominal pain that spreads to your back
- Severe allergic reactions: skin rash, hives, itching, swelling of face or tongue, trouble breathing, chest tightness
- Very high blood sugar levels (diabetic ketoacidosis): tiredness, thirst, dry mouth, fruity breath odor, vomiting, abdominal pain, trouble breathing
The following Serostim (somatropin) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Abnormal or decreased touch sensation
bleeding after defecation
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the urine
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
changes in skin color
cold hands and feet
confusion
cough or hoarseness
darkened urine
decreased urination
difficult urination
dizziness
fainting or loss of consciousness
fast heartbeat
fast or irregular breathing
feeling unusually cold
fever or chills
full or bloated feeling
general feeling of discomfort or illness
headache
increase in heart rate
itching or skin rash
joint pain
light-colored stools
lightheadedness
loss of appetite
lower back or side pain
muscle aching or cramping
muscle pain or stiffness
pain, redness, or swelling in the arm or leg
pains in the stomach, side, or abdomen, possibly radiating to the back
pressure in the stomach
rapid, shallow breathing
rapid weight gain
rectal bleeding
shivering
sore mouth or tongue
stomach bloating, burning, cramping, or pain
sudden decrease in the amount of urine
sweating
swelling of the abdominal or stomach area
swelling of the eyes or eyelids
swelling or puffiness of the face
swollen joints
thirst
tightness in the chest
tingling of the hands or feet
trouble breathing
trouble sleeping
uncomfortable swelling around the anus
unpleasant breath odor
unusual tiredness or weakness
unusual weight gain or loss
vomiting
vomiting of blood
white patches in the mouth, tongue, or throat
wrinkled skin
yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
blurred vision
changes in vision
cold sweats
coma
cool, pale skin
decrease in the amount of urine
extreme weakness
flushed, dry skin
fruit-like breath odor
increase in hands and feet size
increased hunger
increased thirst
increased urination
increased volume of pale, diluted urine
nightmares
noisy, rattling breathing
pain in the arms or legs
seizures
shakiness
slurred speech
stop in menstruation
swelling of the fingers or hands
troubled breathing at rest
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Body aches or pain
breast pain
change in the color, amount, or odor of vaginal discharge
congestion
discoloration of the fingernails or toenails
dryness or soreness of the throat
excess air or gas in the stomach or intestines
frequent urge to defecate
increased sweating
passing gas
straining while passing stool
tender, swollen glands in neck
trouble with swallowing
voice changes
Less common
Discouragement
feeling sad or empty
irritability
lack of appetite
loss of interest or pleasure
tiredness
trouble concentrating
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Serostim (somatropin)
Pros
- One of the few medications FDA approved for HIV-related wasting
- Raises lean body mass, weight gain, and improves physical endurance
- Only needs to be injected once a day at bedtime
Cons
- Need to prepare the injection by mixing and drawing up the medication
- Can cause swelling in the hands and feet and muscle pain
- Can cause changes in your blood sugar, leading to or worsening diabetes
Pharmacist tips for Serostim (somatropin)
- Make sure you know how to prepare and inject this medication. Review the Injection Guide and watch this helpful instructional video.
- Inject Serostim (somatropin) under the skin, into your thigh, upper arm, stomach, or buttock. Make sure you choose a different injection site every day. Using the same site over and over again can lead to lipoatrophy, or loss and damage to the fat tissue at that site.
- Serostim (somatropin) comes in single-use and multi-use vials. Single-use vials should be mixed with sterile water, while multi-use vials should be mixed with bacteriostatic water. Be sure to check which type you have before you prepare your injection.
- Serostim (somatropin) can cause swelling, especially in your hands and feet. It can also cause muscle pain or stiffness. These side effects might go away on their own. But if they don't, let your prescriber know. Your prescriber might suggest taking pain medication or reducing how often you inject Serostim (somatropin).
- Continue to take your HIV antiretroviral (ARV) medications. There's a chance Serostim (somatropin) can speed up HIV growth, so using ARV medications are required to control your viral load.
- To further help treat HIV-related wasting, try to eat foods that have more calories and protein such as cheeses, peanut butter, and eggs. It's also important to regularly exercise to build your muscle mass.
- Store Serostim (somatropin) vials that haven't been mixed yet at room temperature. If you're using a multi-use vial, refrigerate it after mixing with water; it'll be good for 14 days. Single-use vials should be injected right after mixing, then thrown away after injection.
- Throw away used syringes and needles in a sharps container. This lowers the risk of needle-stick injuries. Don't throw them away in your trash can.
Common questions about Serostim (somatropin)
No. Serostim (somatropin) isn't a steroid. It's actually a biologic medication that's similar to human growth hormone.
In general, it typically takes about 17 to 21 hours for most of Serostim (somatropin) to leave your system after a dose. This time frame is estimated based on the half-life of Serostim (somatropin), a measure of how long it takes your body to remove the medication from your system.
Your dose of Serostim (somatropin) depends on your weight. Your prescriber will calculate the correct amount for you to inject. The dose is typically 0.1 mg/kg, injected once a day, with a maximum dose of 6 mg, no matter your weight. But, some people at higher risk for side effects might inject every other day instead. If you have questions about your dosage, discuss them with your prescriber.
Review the Injection Guide for step-by-step directions on how to prepare and inject Serostim (somatropin). After mixing the medication, clean the injection site with an alcohol wipe. After the skin has dried, pinch it with one hand, and with the other, insert the needle as far as it will go. Then, release the skin and push down on the plunger to inject the medication. If you have any questions about how to inject Serostim (somatropin), talk to your prescriber or pharmacist.
Serostim (somatropin) can start working within a few weeks, but it can take up to 12 weeks for you to feel the full effects of the medication if injected daily. And studies have shown that it continues to work for an additional 12 weeks. Contact your prescriber if you see no improvement after 12 weeks, because you might need to switch to a different medication.
No. Don't use Serostim (somatropin) past its expiration date because it might not work as well and could be unsafe. There should be an expiration date that's written on the medication box and vial. If you find that your medication has expired, contact your pharmacist to get another refill.
It's recommended to inject Serostim (somatropin) right before bedtime. Our bodies release natural growth hormone while we sleep, so injecting Serostim (somatropin) right before bed can help you get the most benefit from the medication.
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Risks and warnings for Serostim (somatropin)
Serostim (somatropin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Higher risk of death in people with a short-term critical illness
- Risk factors: Open heart or stomach surgery | Serious injuries | Severe breathing problems
There have been reports of growth hormone medications like Serostim (somatropin) raising the risk of death when used in people with a critical illness from open heart or stomach surgery, serious injuries, or a severe breathing problem. Speak with your prescriber if you have questions or concerns about this warning.
Potential to cause HIV viral growth
During the first research studies for this medication, Serostim (somatropin) caused the HIV virus to replicate (grow). This effect wasn't seen in later, larger studies. But, just to be safe, you'll need to remain on ARV therapy while taking Serostim (somatropin) to control the viral load.
Cancer
- Risk factors: People living with HIV
In general, people living with HIV have a higher risk of getting cancer. Let your prescriber know if you have a history of any type of cancer. They might want to monitor you more closely while you're taking this medication.
High blood sugar
Serostim (somatropin) can lead to high blood sugar and raise your risk of diabetes, especially when you first start taking the medication. Sometimes this rise in blood sugar can be extreme and lead to more dangerous side effects like diabetic ketoacidosis and coma. Contact your prescriber right away if you have symptoms of diabetic ketoacidosis, such as tiredness, vomiting, abdominal pain, thirst, dry mouth, and trouble breathing. You might need to monitor your blood sugar while you're taking Serostim (somatropin).
High blood pressure in the brain (intracranial hypertension)
Rarely, Serostim (somatropin) has caused high blood pressure in the blood vessels in the brain, or intracranial hypertension. This can cause vision changes, headache, nausea, and vomiting. Symptoms usually occur within 2 months after starting treatment. It usually goes away once the medication is stopped or the dose is lowered. Your prescriber will likely perform routine examinations before you start and throughout your treatment with Serostim (somatropin).
Swelling in the hands and feet
Serostim (somatropin) can cause fluid build-up, which can lead to swelling in your body, especially in your hands and feet. This fluid build-up can also cause other conditions such as muscle pain and carpal tunnel syndrome. Sometimes these symptoms improve on their own, with or without pain medications. If not, let your prescriber know because it might require lowering the dose. If carpal tunnel symptoms (e.g., numbness, weakness, and tingling in the hands) continue after lowering the dose, you might need to stop taking Serostim (somatropin).
Swelling of the pancreas (pancreatitis)
- Risk factors: Children | Girls with Turner syndrome
It's rare, but some people taking Serostim (somatropin) develop pancreatitis, or swelling of the pancreas, which can be painful. Symptoms include nausea, vomiting, and stomach pain that spreads to your back. Stop taking Serostim (somatropin) and seek medical help right away if this happens to you.
Serostim (somatropin) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 7 vials of 4mg | 1 carton | $3,441.79 | $3,441.79 |
| 7 vials of 5mg | 4 cartons | $17,183.91 | $4,295.98 |
| 7 vials of 6mg | 4 cartons | $20,619.43 | $5,154.86 |
Typical dosage for Serostim (somatropin)
Your dose of Serostim (somatropin) is based on your weight.
The typical starting dose is 0.1 mg/kg injected under the skin once a day at bedtime. The maximum daily dose is 6 mg, regardless of your weight.
In some people with a higher risk for side effects from recombinant growth hormone treatment, the starting dose might be lower at 0.1 mg/kg injected under the skin every other day.
Interactions between Serostim (somatropin) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
How much does Serostim (somatropin) cost?
$3,441.79
Serostim (somatropin) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Serostim (somatropin) will not be safe for you to take.
- A short-term, critical illness from surgery, serious injuries, or a severe breathing problems
- Currently have cancer
- Active or severe eye damage caused by diabetes (diabetic retinopathy)
What are alternatives to Serostim (somatropin)?
