Ryplazim

Last updated on RxList: 6/17/2021
Ryplazim Side Effects Center

What Is Ryplazim?

Ryplazim (plasminogen, human-tvmh) is plasma-derived human plasminogen used to treat patients with plasminogen deficiency type 1 (hypoplasminogenemia).

What Are Side Effects of Ryplazim?

Side effects of Ryplazim include:

  • abdominal pain,
  • bloating,
  • nausea,
  • fatigue,
  • pain in extremities,
  • bleeding,
  • constipation,
  • dry mouth,
  • headache,
  • dizziness,
  • joint pain, and
  • back pain.

Dosage for Ryplazim

The recommended dosage of Ryplazim is 6.6 mg/kg body weight given every 2 to 4 days.


Ryplazim In Children

The safety and efficacy of Ryplazim has been established in pediatric patients. Use of Ryplazim is supported by the two clinical trials, and expanded access and compassionate use programs that included 18 pediatric patients age 11 months to 17 years.

What Drugs, Substances, or Supplements Interact with Ryplazim?
 

Ryplazim may interact with other medicines.

Tell your doctor all medications and supplements you use.


Ryplazim During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Ryplazim; it is unknown if it would affect a fetus. It is unknown if Ryplazim passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Ryplazim (plasminogen, human-tvmh) Lyophilized Powder for Reconstitution, for Intravenous Use 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.

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.

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Ryplazim Professional Information

SIDE EFFECTS

The most frequent (incidence ≥ 10%) adverse reactions were abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain.

Clinical Trials Experience

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

The safety data described in this section reflect exposure to RYPLAZIM in two single-arm, open-label clinical trials as well as expanded access and compassionate use programs for a total of 29 patients with plasminogen deficiency type 1 who received at least one dose of RYPLAZIM. Patients were between 11 months and 42 years of age. There were 18 pediatric patients and 11 adult patients. Fifteen patients were female. Twenty-eight patients were Caucasian, and one patient was Asian.

RYPLAZIM Trial 1 enrolled 7 patients (5 female) of whom 2 were pediatric patients (age 13 to 15 years) and 5 were adults. Five patients received two infusions: one 2 mg/kg infusion, and one 6 mg/kg infusion. Two patients received a single 6 mg/kg infusion. There were no adverse reactions in this trial.

RYPLAZIM Trial 2 enrolled 15 patients (11 female) of whom 6 were pediatric patients (age 4 to 16 years) and 9 were adults. Six of the 15 patients participated in RYPLAZIM Trial 1. Treatment duration ranged from 48 to 124 weeks. All patients received RYPLAZIM at a dose of 6.6 mg/kg administered every second, third or fourth day for 48 weeks.

A long-term treatment protocol enrolled 12 patients (8 female) of whom 8 were pediatric patients (age 16 months to 16 years) and 4 were adults. Eight patients in this treatment protocol continued from Trial 2 and 4 patients were from individual expanded access protocols in the US. All 12 patients continue to receive RYPLAZIM at the dose of 6.6 mg/kg every 2 to 4 days.

Fourteen patients (5 female) received RYPLAZIM through expanded access programs. There were 8 pediatric patients (age 11 months to 17 years) and 6 adults. Patients’ dosage regimens were adjusted based on clinical response, and the regimens varied between 6.6 mg/kg every 1 to 7 days.

Table 1 shows the most frequent adverse reactions (incidence ≥ 10%) observed in the two trials and in the treatment protocols.

Table 1 Adverse Reactions Reported in ≥ 10% of Patients with Plasminogen Deficiency Type 1 (N=19*)

Adverse Reactions Number of Patients (%)(N = 19)
Abdominal pain 3 (16%)
Gastric dilatation (bloating/feel bloated) 3 (16%)
Nausea 3 (16%)
Fatigue 3 (16%)
Pain in extremity 3 (16%)
Hemorrhage 3 (16%)
Constipation 2 (11%)
Dry mouth 2 (11%)
Headache 2 (11%)
Dizziness 2 (11%)
Arthralgia 2 (11%)
Back pain 2 (11%)
*Age range of patients: 16 months to 42 years.
9 patients who received RYPLAZIM through single-patient expanded access were not included in the total population for the determination of adverse reaction frequency because their safety data were not as rigorously collected as patients in the clinical trials. Also not included is one patient from trial 1 who only received a single dose.

Immunogenicity

In RYPLAZIM Trial 2, three patients (20%) developed anti-plasminogen antibodies following RYPLAZIM treatment. Comparison of pharmacokinetic (PK) parameters and /or trough activity levels for those positive samples with the parameters assessed either at baseline or for negative samples suggest these antibodies are not neutralizing antibodies (inhibitors) to plasminogen.

The detection of anti-plasminogen antibodies depends on the sensitivity and specificity of the test methods used. Additionally, the observed incidence of antibody positivity in a test method may be influenced by several factors, including sample handling, timing of sample collection, drug interference, concomitant medication, and the underlying disease. For these reasons, comparison of the incidence of antibodies to RYPLAZIM with the incidence of antibodies to other products may be misleading.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Ryplazim (Plasminogen, Human-tvm for IV Use)

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

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