Immune Globulin SC

Immune Globulin SC is a prescription medication used to treat the symptoms of primary humoral  immunodeficiency and chronic inflammatory demyelinating polyneuropathy. 

• Immune Globulin SC is available under the following different brand names: Hizentra, HyQvia, Cuvitru, Gammagard Liquid SC, Gamunex-C SC, Cutaquig, Xembify, Immune Globulin SC-klhw.

Common side effects of Immune Globulin SC include:

• Wheezing,
• Trouble breathing,
• Pain, redness, bruising, itching, swelling, or a hard lump at the injection site,
• Fever,
• Tiredness,
• Dizziness,
• Nausea,
• Vomiting,
• Diarrhea,
• Bloating,
• Stomach pain,
• Itching,
• Rash,
• Other skin problems,
• Stuffy nose,
• Sneezing,
• Sore throat,
• Cough,
• Headache,
• Migraine, and
• Pain anywhere in the body

Serious side effects of Immune Globulin SC include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Wheezing,
• Chest tightness,
• Dizziness,
• Lightheadedness,
• Pale or yellow skin,
• Dark-colored urine,
• Fever,
• Confusion,
• Weakness,
• Little or no urination,
• Swelling,
• Rapid weight gain,
• Shortness of breath,
• Chest pain,
• Blue-colored lips, fingers, or toes,
• Fever with a severe headache,
• Neck stiffness,
• Eye pain,
• Increased sensitivity to light,
• Chest pain with deep breathing,
• Rapid heart rate,
• Numbness or weakness on one side of the body, and
• Swelling and warmth or discoloration in an arm or leg

Rare side effects of Immune Globulin SC include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Subcutaneous injectable solution

• 10% (100 mg/mL) (Gamunex-C, Gammagard Liquid)
• 10% (100 mg/mL) duovial set with recombinant human hyaluronidase 160 units/mL (HyQvia)
• 16.5% (165 mg/mL) (Cutaquig)
• 20% (200 mg/mL) (Hizentra, Cuvitru, Xembify)

Primary Humoral Immunodeficiency

Adult dosage

• Hizentra
  • May be administered as a subcutaneous infusion at regular intervals as daily up to biweekly (i.e., every 2 weeks)
  • Before initiating, obtain serum IgG trough level to guide subsequent dose adjustments.
  • Weekly dosing
    • Start 1 week after the last IGIV infusion.
    • Initial weekly dose: 1.37 x previous IVIG dose (in grams) divided by the number of weeks between IVIG doses.
  • Biweekly dosing (ie, every 2 weeks)
    • Start treatment 1 or 2 weeks after the last IGIV infusion or 1 week after that last weekly Hizentra infusion.
    • Administer twice the calculated weekly dose.
  • Frequent dosing (2-7 times/week)
    • Divide the calculated weekly dose by the desired number of dosage times per week.
• Gamunex-C
  • Administered as a weekly subcutaneous infusion.
  • Initial SC dose: 1.37 x current IVIG dose in mg/kg divided by the number of weeks between intravenous doses.
  • Not to exceed 20 mL/hour/infusion site
• Gammagard Liquid
  • Administered as a weekly subcutaneous infusion.
  • Initial subcutaneous dose: Initial subcutaneous dose: 1.37 x current IVIG dose in mg/kg divided by the number of weeks between intravenous doses.
  • Above 40 kg: Not to exceed 30 mL/infusion site at the rate of 20 mL/hour/site; for maintenance dose, may increase to 30 mL/hour site.
  • Below 40 kg: Not to exceed 20 mL/infusion site at the rate of 15 mL/hour site; for maintenance dose, may increase to 20 mL/hour site.
• HyQvia
  • Initiating
    • For patients previously on another IgG treatment, administer the first dose approximately 1 week after the last infusion of their previous treatment.
    • Increase the dose and frequency from a 1-week dose to a 3- or 4-week dose (see titration schedule)
    • Initiating treatment at a full monthly dose was not evaluated in clinical trials.
  • Titration schedule
    • Titrate to dosage interval of every 3-4 weeks.
    • Week 1: 1st infusion (weekly dose) at 25% of the targeted dose
    • Week 2: 2nd infusion (every 2-week dose) at 50% of the targeted dose
    • Week 3: No infusion
    • Week 4: 3rd infusion (every 3-week dose) at 75% of the targeted dose
    • Week 5: No infusion
    • Week 6: No infusion
    • Week 7: 4th infusion (every 4week dose) at 100% of the targeted dose (if required)
  • Switching from IVIG
    • Administer HyQvia at the same dose and frequency as the previous intravenous treatment, after the initial dose titration.
    • Patients naïve to IgG treatment or switching from Immune Globulin to human subcutaneous.
    • 300-600 mg/kg subcutaneous at 3 to 4-week intervals, after initial titration
• Cuvitru or Cutaquig
  • Can be administered at regular intervals from daily up to every 2 weeks.
  • Initiating
    • Individualize the dose based on the patient’s pharmacokinetic and clinical response.
    • Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed.
  • Switching from IVIG or adults switching from HyQvia
    • Begin 1 week after the patient’s last IGIV or HyQvia infusion.
    • Establish the initial weekly dose by converting the monthly IGIV or HyQvia dose into an equivalent weekly dose and increasing it using a dose adjustment factor.
    • To calculate the initial weekly dose, divide the previous IGIV or HyQvia dose in grams by the number of weeks between Intravenous doses; then multiply this dose by the dose adjustment factor of 1.3.
    • Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state.
  • Switching from another Immune Globulin human subcutaneous (IGSC)
    • Weekly dose (in grams) is recommended to be the same as the weekly dose of prior IGSC treatment (in grams)
    • Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state.
• Xembify
  • Before initiating, obtain serum IgG trough level to guide subsequent dose adjustments.
  • Doses divided over the course of a week, or every week achieve similar exposure when administered regularly at steady-state
  • For frequent dosing (2-7 times/week), divide the calculated weekly dose by the desired number of dosage times per week.
  • Monitor IgG trough level every 2-3 months to determine subsequent dose adjustments and dosing intervals as needed.
  • Consider the patient’s clinical response in dose adjustment; if an adequate clinical response or a serum IgG trough level equivalent to that of a previous treatment is not maintained, adjust the dose; accordingly, refer to the prescribing information for further information.
  • Switching from IVIG
    • Start 1 week after the last IGIV infusion.
    • Initial weekly dose: 1.37 x previous IVIG dose (in grams) divided by the number of weeks between IVIG doses
  • Switching from another IGSC
    • Administer the same weekly dose of Xembify (in grams) as the weekly dose of prior IGSC treatment (in grams)
    • Pediatric dosage
      • Below 2 years: Safety and efficacy not established.
      • Individualize dose based on patient’s clinical response and serum IgG trough levels; obtain baseline serum IgG trough level to guide subsequent dosage adjustments.
      • Before initiating, ensure that patients have received IGIV treatment at regular intervals for at least 3 months.
• Hizentra
  • May be administered as a weekly or biweekly (i.e., every 2 weeks) subcutaneous infusion.
  • Initial subcutaneous weekly dose: 1.53 x current IVIG dose in mg/kg divided by the number of weeks between Intravenous doses.
  • Initial subcutaneous biweekly dose: For biweekly dosing, start treatment 1 or 2 weeks after the last IGIV infusion or 1 week after that last weekly Hizentra infusion.
  • subcutaneous infusion volume: Not to exceed 15 mL/infusion site; for maintenance dose, may increase to 20 mL/site after 4th infusion, and then 25 mL/site as tolerated.
  • subcutaneous infusion rate: Not to exceed 15 mL/hour/site for 1st dose; may increase to 25 mL/hour/site for subsequent infusions.
• Cuvitru or Cutaquig
• Can be administered at regular intervals from daily up to every 2 weeks.
  • Initiating
    • Individualize the dose based on the patient’s pharmacokinetic and clinical response.
    • Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed.
  • Switching from IVIG or adults switching from HyQvia
    • Begin 1 week after the patient’s last IGIV or HyQvia infusion.
    • Establish the initial weekly dose by converting the monthly IGIV or HyQvia dose into an equivalent weekly dose and increasing it using a dose adjustment factor.
    • To calculate the initial weekly dose, divide the previous IGIV or HyQvia dose in grams by the number of weeks between intravenous doses; then multiply this dose by the dose adjustment factor of 1.3.
    • Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state.
  • Switching from another Immune Globulin human subcutaneous
    • Weekly dose (in grams) is recommended to be the same as the weekly dose of prior IGSC treatment (in grams)
    • Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state.
• Gamunex-C
  • Administered as a weekly subcutaneous infusion.
  • Initial weekly subcutaneous dose: 1.37 x current IVIG dose in mg/kg divided by the number of weeks between intravenous doses.
• Gammagard Liquid
  • Administered as a weekly subcutaneous infusion.
  • Initial SC dose: Initial SC dose: 1.37 x current IVIG dose in mg/kg divided by the number of weeks between intravenous doses.
  • Above 40 kg: Not to exceed 30 mL/infusion site at a rate of 20 mL/hour/site; for maintenance dose, may increase to 30 mL/hour site.
  • Below 40 kg: Not to exceed 20 mL/infusion site at a rate of 15 mL/hour site; for maintenance dose, may increase to 20 mL/hour site.
• Xembify
  • Before initiating, obtain serum IgG trough level to guide subsequent dose adjustments.
  • Doses divided over the course of a week or every Week achieve similar exposure when administered regularly at steady-state
  • For frequent dosing (2-7 times/week), divide the calculated weekly dose by the desired number of dosage times per week
  • Monitor IgG trough level every 2-3 months to determine subsequent dose adjustments and dosing intervals as needed
  • Consider the patient’s clinical response in dose adjustment; if an adequate clinical response or a serum IgG trough level equivalent to that of a previous treatment is not maintained, adjust the dose; accordingly, refer to the prescribing information for further information
  • Switching from IVIG
    • Start 1 week after the last IGIV infusion.
    • Initial weekly dose: 1.37 x previous IVIG dose (in grams) divided by the number of weeks between IVIG doses.
  • Switching from another IGSC
    • Administer the same weekly dose of Xembify (in grams) as the weekly dose of prior IGSC treatment (in grams)

Chronic Inflammatory Demyelinating Polyneuropathy

Adult dosage

• Hizentra only
• Initiate weekly dosing 1 week after the patient’s last IGIV dose.
  • Initial dose
    • 0.2 g/kg (1 mL/kg) SC per week, administered in 1 or 2 sessions over 1 or 2 consecutive days.
• If CIDP symptoms worsen
  • If CIDP symptoms worsen at 0.2 g/kg/week, consider increasing the dose to 0.4 g/kg/week Subcutaneous administered in 2 sessions per week over 1-2 consecutive days.
  • If CIDP symptoms worsen at 0.4 g/kg/week, consider reinitiating therapy with an IGIV product approved for the treatment of CIDP, while discontinuing Hizentra
  • Monitor the patient’s clinical response and adjust the duration of therapy based on the patient’s needs.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Immune Globulin SC has severe interactions with no other drugs.
• Immune Globulin SC has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Immune Globulin SC has moderate interactions with the following drugs:
  • BCG vaccine live.
  • efgartigimod alfa
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live.
  • measles, mumps, rubella, and varicella vaccine, live.
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live.
  • varicella virus vaccine live.
• Immune Globulin SC has minor interactions with the following drugs:
  • ethotoin
  • fosphenytoin
  • phenytoin
  • protein a column

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to Immune Globulins or solution components
• Selected IgA deficiency with known antibody against IgA
• Severe thrombocytopenia or coagulation disorders
• Hyperprolinemia (Hizentra contains the stabilizer L-proline)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Immune Globulin SC?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Immune Globulin SC?”

Cautions

• Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG (see Contraindications)
• Thrombosis may occur following treatment with Immune Globulin products; risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors; monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
• Aseptic meningitis syndrome (AMS) reported to occur with IgG products; discontinuation of IgG treatment resulted in remission of AMS within several days without sequelae; syndrome usually begins within several hours to 2 days following intravenous administered IgG, perhaps more frequently in association with high dose (2 g/kg) intravenous administered IgG.
• Infusion into or around an infected area can spread a localized infection; do not infuse HyQvia into these areas due to the potential risk of spreading a localized infection Initial treatment should be done in a clinical setting (due to the possibility of anaphylactic reactions)
• Products made from human plasma can contain infectious agents (. g, viruses and, theoretically, Creutzfeldt-Jakob disease [CJD])
• Subcutaneous administration associated with an increased risk of hematoma.
• Hemolytic anemia reported (monitor)
• Renal dysfunction or renal failure has been associated with IG therapy; monitor renal function and urine output.
• Hyperproteinemia and hyponatremia may occur.
• In clinical studies, eighteen percent of subjects receiving HyQvia developed non-neutralizing antibodies to the recombinant human hyaluronidase component; potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm; unknown whether these antibodies may interfere with fertilization in humans or its clinical significance.
• Noncardiogenic pulmonary edema may occur in patients following treatment with human Immune Globulin products.
• Drug interactions overview
  • Live virus vaccines
    • Passive transfer of antibodies with immunoglobulin administration may interfere with response to live virus vaccines (. g, measles, mumps, rubella, varicella) HyQvia may impair the immune response to live attenuated virus vaccines (. g, mumps, rubella, varicella) for up 6 months and for a year or more to measles
• Interference with laboratory tests
  • Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of the results of serological testing.
  • Passive transmission of antibodies to erythrocyte antigens (. g, A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test
  • Administration of Cuvitru can lead to false positive readings in assays that depend on the detection of beta-D-glucans for diagnosis of fungal infections; this may persist during the weeks following infusion of the product.

Pregnancy and Lactation

• No human data are available to indicate the presence or absence of drug-associated risk.
• Unknown whether Immune Globulin SC can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Immune Globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation; therefore, the drug should be given to pregnant women only if needed
• Lactation
  • No human data are available to indicate the presence or absence of drug-associated risk.
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Immune Globulin SC and any potential adverse effects on the breastfed infant from Immune Globulin SC or from the underlying maternal condition.