Medical Editor: John P. Cunha, DO, FACOEP
What Is Xembify?
Xembify (immune globulin subcutaneous, human–klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older.
What Are Side Effects of Xembify?
Common side effects of Xembify include:
- infusion site reactions (redness, pain, swelling, bruising, hard lump itching, firmness, scabbing),
- cough, and
Dosage for Xembify
The dose of Xembify is individualized based on the patient's pharmacokinetic and clinical response.
What Drugs, Substances, or Supplements Interact with Xembify?
Xembify During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Xembify; it is unknown how it would affect a fetus. It is unknown if Xembify passes into breast milk. Consult your doctor before breastfeeding.
Our Xembify (immune globulin subcutaneous, human–klhw) 20% Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The most common adverse reactions in ≥ 5% of subjects in the clinical trial were local adverse reactions including infusion site erythema (redness), infusion site pain, infusion site swelling (puffiness), infusion site bruising, infusion site nodule, infusion site pruritus (itching), infusion site induration (firmness), infusion site scab, infusion site edema, and systemic reactions including cough and diarrhea.
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical safety data are based on an open-label, single-arm prospective multi-center study of 49 subjects with primary immunodeficiency (PI) who received subcutaneous XEMBIFY for at least 6 months.
A total of 49 subjects received 1053 XEMBIFY infusions, including 14 subjects between 2 to 16 years of age during the clinical trial. The average number of infusions per subject was 21.5 infusions, median 24 infusions (range 1-26 infusions). There were a total of 390 local infusion site reactions which occurred at a rate per infusion of 0.370 (about 1 in 2.7 infusions). Of these, the most common was infusion site erythema which had a median duration of 24.9 hours. Infusion site swelling, and infusion site pain had median durations of 24.5 and 22.8 hours, respectively. Local infusion site reactions of all kinds by site of infusion (where site of infusion was recorded) occurred in 50.0% and 52.6% of patients during infusions in the abdomen versus thigh, respectively, and across 773 abdominal infusions and 279 thigh infusions rates were 0.184 and 0.735 per infusion, respectively; this corresponds to 1 in 5.4 infusions (for abdomen) and 1 in 1.4 infusions (for thigh). No local infusion site reactions were severe or serious.
The adverse reactions occurring in ≥ 5% of subjects on XEMBIFY in the clinical trial for the duration of the subcutaneous (SC) phase are depicted in the table below which includes all treatment-emergent adverse reactions except infections.
Table 2: Adverse Reactions in ≥ 5% of
Subjects During Infusions of XEMBIFY
|Adverse Reaction*||By Subject n (%)†
|By Infusion n (rate)‡
|Infusion site erythema||19 (39%)||123 (0.117)|
|Infusion site pain||9 (18%)||32 (0.030)|
|Infusion site swelling||8 (16%)||124 (0.118)|
|Infusion site bruising||8 (16%)||26 (0.025)|
|Infusion site nodule||8 (16%)||13 (0.012)|
|Infusion site pruritus||5 (10%)||28 (0.027)|
|Infusion site induration||4 (8%)||6 (0.006)|
|Infusion site scab||3 (6%)||6 (0.006)|
|Infusion site edema||3 (6%)||5 (0.005)|
|Cough||3 (6%)||4 (0.004)|
|Diarrhea||3 (6%)||3 (0.003)|
|* Including all adverse reactions that occurred after the
first dose ofXEMBIFY regardless of causality, excluding infections.
† Number and percentage o f subjects with the adverse reaction.
‡ Rate per infusion is calculated as the total number ofadverse reactions divided by the total number of infusions.
Four subjects discontinued XEMBIFY due to adverse reactions which were infusion site nodules, infusion site discomfort, skin papules/plaques, and arthralgia/myalgia.
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
The following adverse reactions have been identified and reported during the postmarketing use of immune globulin products administered subcutaneously:
Cardiac disorders: Tachycardia
Nervous system disorders: Tremor and paresthesia
Respiratory, thoracic and mediastinal disorders: Dyspnea and laryngospasm
Read the entire FDA prescribing information for Xembify (Immune Globulin Subcutaneous, Human – klhw Injection)