Cutaquig
Cutaquig is an immunoglobulin (also known as antibody) used to treat primary humoral immunodeficiency (PI) in people 2 years and older. This condition happens when your immune system is missing or isn't working like it should. Cutaquig is given as an injection under the skin through an infusion pump and can be given at home.
What is Cutaquig?
What is Cutaquig used for?
- Trouble fighting infections (primary humoral immunodeficiency or PI)
How Cutaquig works
Cutaquig is a replacement for immunoglobulin G (IgG). IgG is one type of antibody that your immune system naturally makes to help you fight off things that make you sick, like viruses and bacteria.
But if you have certain medical conditions like PI, your immune system is either missing or isn't working like it should. This can lead to problems like infections.
The exact way Cutaquig works isn't completely known. But it's thought to work by boosting your immune system to help prevent infections.
Drug facts
Side effects of Cutaquig
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
Adults:
- Swelling, redness, or itching at injection site (72%)
- Headache (19%)
- Skin irritation or inflammation (12%)
- Fever (12%)
- Diarrhea (12%)
Children:
- Swelling, redness, or itching at injection site (74%)
- Asthma (11%)
- Cough (11%)
- Vomiting (11%)
Less Common Side Effects
Adults:
- Muscle spasms
- Back or joint pain
Children:
- Stuffy nose
- Fever
- Headache
- Pain in mouth and throat
- Stomach pain
- Ear pain
- Skin irritation or inflammation
- Hives
- Low white blood cell count
Cutaquig serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Blood clot: in the lungs (cough, difficulty breathing, chest pain); in the legs (redness, pain, tenderness, swelling of the skin); near the heart (chest pain, pain in the arms or shoulders, pain in the neck or jaw); in the brain (difficulty speaking, numbness on one side of the body, confusion)
- Serious allergic reaction (anaphylaxis): difficulty breathing, tightness in the throat, hives, fast heartbeat, dizziness, lightheadedness, swelling in the face or tongue
- Brain inflammation: severe headache, neck stiffness, sensitivity to light, painful eye movements
- Kidney problems: tiredness, dry and itchy skin, low appetite, urinating less than usual, foamy or bloody urine, muscle cramps
- Breakdown of red blood cells: tiredness, dizziness, weakness, yellowing of the skin or eyes, dark-colored urine
- Lung problems: severe breathing problems, wheezing or rattling while breathing, chest pain, fever, headache
The following Cutaquig 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 or nurse immediately if any of the following side effects occur:
More common
Back pain
black, tarry stools
blurred vision
chest pain or tightness
chills
dark urine
decreased urination
dizziness
fast, pounding, or irregular heartbeat or pulse
general feeling of discomfort or illness
headache
joint pain
loss of appetite
muscle aches and pains
nervousness
noisy breathing
pain in the arms or legs
painful or difficult urination
pounding in the ears
rash
shivering
slow or fast heartbeat
sores, ulcers, or white spots on the lips or in the mouth
stomach pain
sweating
swollen glands
trouble sleeping
trouble breathing
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
yellow eyes or skin
Less common
Bluish coloring of the lips or nail beds
burning sensation in the head
faintness or lightheadedness
Rare
Difficulty with swallowing
hives or welts
itching, especially of the feet or hands
reddening of the skin, especially around the ears
swelling of the eyes, face, or inside of the nose
Incidence not known
Back, leg, or stomach pains
blistering, peeling, or loosening of the skin
blood in the urine
change in vision
changes in blood pressure
changes in urination
chest pain or discomfort
cold, clammy, or pale skin
confusion
decreased frequency or amount of urine
difficult or labored breathing
difficulty seeing at night
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
feeling of warmth
headache that is severe and occurs suddenly
hoarseness
increased sensitivity of the eyes to sunlight
increased thirst
irritation
joint stiffness or swelling
light-colored stools
loss of appetite
loss of consciousness
low blood pressure or pulse
lower back or side pain
muscle spasm or jerking of all extremities
pains in the chest, groin, or legs, especially calves of the legs
seizures
shakiness in the legs, arms, hands, or feet
skin blisters
slow breathing
slurred speech that occurs suddenly
sudden, severe weakness or numbness in the arm or leg
sweating
swelling of the face, fingers, lower legs, or ankles
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:
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.
Pros and cons of Cutaquig
Pros
- Can be given at home after receiving training
- FDA approved for use in children as young as 2 years old
- Many dosing schedule options available (e.g., daily, weekly, every other week)
- Can be stored at room temperature for up to 9 months, making it convenient for travel
Cons
- Must be given by an injection
- Has a lot of potential risks, such as kidney and lung problems
- Might be difficult for some people to administer as instructed
- Available as brand name only, which can be expensive
Pharmacist tips for Cutaquig
- Make sure to mark your appointments to see your provider on your calendar so you're properly monitored during Cutaquig treatment.
- Cutaquig is given as an injection under your skin through an infusion pump into either your stomach, thighs, upper arms, or upper leg or hip area.
- Mild-to-moderate reactions at the injection site (e.g., swelling, redness, itching) are common. If you experience severe or worsening reactions, especially during the infusion, stop the infusion and contact your provider right away. If you're having difficulty breathing or feel your throat or tongue start to swell up, call 911 or seek medical help.
- Cutaquig raises your risk for blood clots. Stay well hydrated before each Cutaquig dose to help prevent blood clots. Get medical help right away if you experience symptoms of a blood clot, such as swelling, pain, tenderness, difficulty breathing, and chest pain.
How to inject Cutaquig at home
- Carefully review the instructions to make sure you give yourself Cutaquig injections safely. Let your provider or pharmacist know if you have any questions.
- To help keep track of your treatment, use the Cutaquig journal to write down important information about your infusions. Peel off the removable part of the label on each vial you used, stick it in your journal, and log the date and time of your infusion.
- You can use up to 6 injection sites at the same time to inject your Cutaquig dose. Make sure they're at least 2 inches apart from each other to avoid skin damage. For your next dose, use different sites from the last time.
- Store Cutaquig vials in the refrigerator for up to 3 years from the date of manufacture. Don't freeze the medication. Or, you can store the vials at room temperature for up to 9 months. Keep the vials in the original container away from light.
- When it's time for your dose, take Cutaquig out of the refrigerator and allow it to reach room temperature. This will take at least an hour and a half. Don't try to warm up the medication any other way (e.g., microwave, under hot water) because you might damage it.
- Always check to make sure the medication is clear and colorless to pale yellow before using it. If it's cloudy, discolored, has particles, or the cap of the syringe or vial is missing, don't use it. Contact your or your child's provider or pharmacist to see if it's possible to get a replacement.
- Throw away used syringes and needles in a sharps container or something made of heavy-duty plastic (e.g., empty milk carton, laundry detergent bottle) to lower the risk of needlestick injuries. Don't throw them away in your trash can. For more information on how to throw away your sharps container safely, visit the FDA's website.
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Risks and warnings for Cutaquig
Cutaquig 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.
Risk of blood clots
- Risk factors: Older age | Not moving much or on bed rest | History of blood clots | Medical conditions that raise your risk of blood clots | Taking medications that contain estrogen | Central IV lines | Have thick blood | Having risk factors for heart problems
Cutaquig can raise your risk of getting blood clots in various parts of your body. Symptoms of a blood clot might be different depending on the location of the clot. They can include swelling, warmth, or tenderness in the legs. But more seriously, clots can lead to breathing problems, heart problems, or stroke and cause chest pain; difficulty breathing; or weakness of the face, legs, or arms. Call 911 if you have any of these symptoms because this is a medical emergency.
Your provider will monitor you closely for blood clot symptoms while you receive Cutaquig. If you're at risk for blood clots, your provider might adjust your dose and infusion rate. Make sure you're well hydrated before using Cutaquig to help prevent blood clots from happening.
Serious allergic reactions
Serious allergic reactions to Cutaquig are possible, including life-threatening reactions like anaphylaxis (e.g., closing of the throat). If you notice dizziness, sweating, nausea, a choking sensation, difficulty breathing, swelling around your eyes, or swelling of the lips or tongue after using Cutaquig, stop the infusion and get medical attention right away.
Falsely high blood sugars
- Risk factors: Type 1 or type 2 diabetes | Using insulin | Using glucose meters that use GDH-PQQ
Cutaquig contains maltose, which is a type of sugar that can cause your blood sugar readings to be falsely high if you use certain glucose monitors that use a substance called GDH-PQQ to detect blood sugar. This raises your risk for low blood sugar (hypoglycemia) if you give yourself insulin to correct this falsely high blood sugar. Contact your local pharmacist or the manufacturer of the glucose monitor test you use if you're not sure if it can be used with products that have maltose in them.
Swelling (inflammation) of the brain
Although rare, some people treated with human immune globulin products like Cutaquig experienced brain inflammation (aseptic meningitis). It can start to happen within a few hours to 2 days after receiving the medication. Typically, it goes away within several days after stopping treatment. Contact your provider if you experience symptoms of meningitis, including severe headache, neck stiffness, sleepiness, fever, sensitivity to light, painful eye movements, nausea, or vomiting.
Kidney problems
- Risk factors: Older than 65 years | History of kidney problems | High blood sugar | Sepsis | Having high amounts of certain proteins in blood (paraproteinemia) | Not enough fluids in the body | Taking medications that can cause kidney problems
Human immune globulin products like Cutaquig can cause severe, and even fatal, kidney problems. Your risk is higher if you have certain factors like older age, diabetes, or taking medications that can cause kidney problems. Your provider will order lab tests to monitor your kidney health before and during treatment with Cutaquig. If your kidney health worsens, your provider might stop your Cutaquig treatment. Contact your provider if you develop any signs or symptoms of kidney failure, including changes in your need to urinate, tiredness, dry and itchy skin, low appetite, and muscle cramps.
Breakdown of red blood cells
- Risk factors: Doses of 2 grams/kg or higher | Blood type other than O
Cutaquig can cause your body to rapidly destroy your red blood cells. Your provider will monitor your blood cell counts during treatment to makes sure your red blood cell count doesn't drop too low. Contact your provider if you experience symptoms of anemia such as tiredness, dizziness, and weakness.
Lung problems
Human immune globulin products like Cutaquig can cause a condition called transfusion-related acute lung injury (TRALI). This condition happens when fluid backs up in your lungs, typically occurring within 1 to 6 hours after receiving the medication. Let your provider know immediately if you experience symptoms of lung injury like severe breathing problems, chest pain or tightness, a racing heartbeat, or fever.
Infection
Because Cutaquig is made from human blood products, there's a risk that it might contain viruses that can make you sick. But your risk of infection is low, since donors of these blood products are carefully screened. Also, there are high manufacturing standards put into place to make sure the viruses are killed or removed. To prevent serious infections in the rare case that your doses of Cutaquig are affected, let your provider know right away if you start to feel sick or have symptoms, such as feeling confused and anxious, or having trouble maintaining your balance.
Cutaquig dosage
Typical dosage for Cutaquig
Cutaquig is given as an injection under the skin using an infusion pump.
Your dose depends on your body weight, previous dose of immune globulin therapy, and lab results. Your provider will calculate and adjust your dose, your infusion rate, and how often you need infusions based on how well you respond to the medication.
Your provider might also change your dose if you're at risk of measles exposure (e.g., traveling to certain places) or if you were exposed to measles.
Interactions between Cutaquig 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.
Cutaquig 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 Cutaquig will not be safe for you to take.
- Severe allergy to human immune globulin
- Immunoglobulin A deficiency with antibodies against IgA and a history of allergic reaction to human immune globulin
What are alternatives to Cutaquig?
Conditions where your immune system is missing or not working like it should:
