Asceniv

Last updated on RxList: 4/18/2019
Asceniv Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/18/2019

Asceniv (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). Common side effects of Asceniv include:

The recommended dose of Asceniv for replacement therapy in primary humoral immunodeficiency (PI) is 300 to 800 mg/kg body weight administered every 3 to 4 weeks. Asceniv may interact with live attenuated virus vaccines such as measles, mumps, rubella, and varicella. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant or plan to become pregnant before using Asceniv; it is unknown how it would affect a fetus. It is unknown if Asceniv passes into breast milk. Consult your doctor before breastfeeding.

Our Asceniv (immune globulin intravenous, human – slra) 10% Liquid 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.

Asceniv Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in your face.

Call your doctor at once if you have:

  • a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;
  • lung problems--chest pain, trouble breathing, blue colored lips, fingers, or toes;
  • signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
  • signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common side effects may include:

  • headache, back pain, joint pain;
  • fever, chills, sweating, warmth or tingling;
  • stomach pain, nausea, diarrhea;
  • increased blood pressure, fast heartbeats;
  • dizziness, tiredness, lack of energy;
  • stuffy nose, sinus pain; or
  • pain, swelling, burning, or irritation around the IV needle.

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.

Read the entire detailed patient monograph for Asceniv (Immune Globulin Intravenous, Human - slra for Injection)

Asceniv Professional Information

SIDE EFFECTS

The most common adverse reactions to ASCENIV (reported in ≥5% of clinical study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice.

In a multicenter, open-label, non-randomized clinical trial, 59 subjects with PI, on regular IGIV replacement therapy, received doses of ASCENIV ranging from 284 to 1008 mg/kg (mean dose 505 mg/kg) every 3 weeks or 4 weeks for up to 12 months (mean 346 days; range 36 to 385 days) (see Clinical Studies). The use of pre-medication was discouraged; however, if after two infusions of ASCENIV subjects required pre-medication (antipyretic, antihistamine, or antiemetic agent) for recurrent reactions, they could continue those medications for the duration of the trial. Of the 793 infusions administered during this trial, only 7 (11.9%) subjects received premedication prior to 7 (0.9%) infusions.

Fifty-eight subjects (98%) had an adverse reaction during the study. The proportion of subjects who had at least one adverse reaction was similar for both the 3- and 4-week cycles. The most common adverse reactions observed in this clinical trial were headache (22 subjects, 37%), sinusitis (16 subjects, 27%), diarrhea (14 subjects, 23%), gastroenteritis viral (13 subjects, 22%), nasopharyngitis (13 subjects, 22%), upper respiratory tract infection (13 subjects, 22%), bronchitis (12 subjects, 20%), nausea (12 subjects, 20%), and acute sinusitis (11 subjects, 19%).

Adverse reactions (ARs) occurring during or within 72 hours after the end of an infusion are presented in Table 2. In this study, the upper bound of the 1-sided 95% confidence interval for the proportion of ASCENIV infusions with one or more temporally associated adverse reactions was 16.4%. The total number of adverse reactions was 158 (a rate of 0.20 ARs per infusion).

Table 2: Adverse Reactions (ARs) (within 72 hours after the end of an ASCENIV infusion) in ≥ 5% of Subjects

Preferred Term (MedDRA v16.0) Number (%) of Subjects
(N=59)
Number (%) of Infusions
(N=793)
Headache 14 (24) 21 (2.6)
Sinusitis 6 (10) 7 (0.9)
Nausea 5 (9) 5 (0.6)
Acute sinusitis 4 (7) 4 (0.5)
Fatigue 4 (7) 9 (1.1)
Muscle spasms 4 (7) 4 (0.5)
Bronchitis 3 (5) 3 (0.4)
Diarrhea 3 (5) 3 (0.4)
Nose Bleed 3 (5) 4 (0.5)
Muscle Pain 3 (5) 5 (0.6)
Oropharyngeal pain 3 (5) 3 (0.4)
Pain in extremity 3 (5) 3 (0.4)
Itching 3 (5) 3 (0.4)

Postmarketing Experience

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 post-approval use of IGIV products:

  • Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), cyanosis, dyspnea, bronchospasm.
  • Cardiovascular: Cardiac arrest, vascular collapse, hypotension.
  • Neurological: Coma, loss of consciousness, seizures, tremor.
  • Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis.
  • Hematologic: Pancytopenia, leukopenia,.
  • General/Body as a Whole: Pyrexia, rigors.
  • Gastrointestinal: Hepatic dysfunction, abdominal pain.

Read the entire FDA prescribing information for Asceniv (Immune Globulin Intravenous, Human - slra for Injection)

© Asceniv Patient Information is supplied by Cerner Multum, Inc. and Asceniv Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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